CompletedNCT03389555Updated Feb 16, 2021Results posted

Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

A Phase 2/3 interventional study of vitamin C, vitamin B1, hydrocortisone and Normal saline in Sepsis, Septic Shock and Metabolic Disturbance, sponsored by Beth Israel Deaconess Medical Center. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-16.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it

Registry

Sepsis — the first condition term the registry derived for this study.

ClinicalTrials.gg

Shock, Septic

Why

The study's listed conditions name Shock, Septic, a narrower term within Sepsis.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Beth Israel Deaconess Medical Center · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 205
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

Read the detailed description

Sepsis and Septic Shock are common and highly morbid clinical conditions without any specific therapy aside from antibiotics. A recent quasi-experimental study (Marik et. al., PMID 27940189) demonstrated a remarkable benefit when the combination of Ascorbic Acid (Vitamin C), Corticosteroids, and Thiamine (Vitamin B1) were given to patients with sepsis. In particular, patients who received this combination of medications required a shorter amount of time on vasopressors, suffered less organ failure, and had improved mortality. Vitamin C has long been suggested for treatment of patients with severe infection as it exerts significant anti-oxidant effects and reduces endothelial permeability. Corticosteroids, a mainstay of therapy for refractory shock in sepsis, have also been shown to enhance the beneficial cellular effects of vitamin C. Finally, thiamine has been shown to be an effective mitochondrial resuscitator in sepsis, especially for the \~30% of septic shock patients who present with thiamine deficiency (Donnino et. al, PMID 26771781).

In this study, we aim to reproduce the findings of Marik et. al. using a more rigorous study design (i.e. a blinded, randomized clinical trial) and focus on the important clinical outcomes of organ failure and death.

Conditions studied

Sepsis
Septic Shock
Metabolic Disturbance

Browse trials for

Sepsis 2,416Registry's first term
Shock, Septic 1,078Primary · reclassified

Keywords

Sepsis
Metabolic Resuscitation

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 205 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.

Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.

Browse Beth Israel Deaconess Medical Center studies →

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adult patient (age ≥ 18 years)
Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

Exclusion criteria

Exclusion Criteria:

Member of a protected population (pregnant, prisoner)
Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
End stage renal disease (ESRD) requiring dialysis
Known Glucose-6-Phosphate Dehydrogenase deficiency
Known Hemachromatosis
Comfort Measures Only status
Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
Clinical indication for (e.g. chronic use) as determined by the clinical team providing this drug
Clinical indication for thiamine as determined by the clinical team providing this drug
Clinical indication for ascorbic acid as determined by the clinical team providing this drug
Known allergy to vitamin C, hydrocortisone, or thiamine

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 205 participants (actual)

Study arms

Experimental
Vitamin C, Vitamin B1, Corticosteroids
The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days
Drug: vitamin C, vitamin B1, hydrocortisone
Placebo comparator
Placebo
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Drug: Normal saline

Interventions

Drugvitamin C, vitamin B1, hydrocortisone
Drug pages: Ascorbic Acid · Thiamine · Hydrocortisone
Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9% NACL(normal saline) and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.
Also known as: Ascorbic Acid, Thiamine
DrugNormal saline
Normal saline (0.9% NaCl solution) volume to match all components

What researchers measure

Primary outcomes

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours. The SOFA score ranges from a minimum of 0 to a maximum of 24, with higher scores meaning worse outcomes.
Time frame: Enrollment to 72-hours

Secondary outcomes

Renal Failure
Development of renal failure as defined by a Kidney Disease Improving Global Outcomes \[KDIGO\] stage 3 or higher. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output \< 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output \<0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy
Time frame: Enrollment until 7-days or discharge from the ICU
30-day Mortality
Mortality rate
Time frame: Enrollment until 30-days after enrollment

Other outcomes

Ventilator Free Days
Days not receiving invasive mechanical ventilation
Time frame: Ventilator free days over the first 7-days after enrollment
Shock Free Days
Days not receiving vasopressor
Time frame: Vasopressor free days over the first 7-days after enrollment
ICU Free Days
Number of days that the patient was not in the ICU. Timeframe listed below.
Time frame: From enrollment until 28 days after enrollment
Hospital Mortality
Hospital mortality rate
Time frame: Enrollment until hospital discharge, death, or 30-days. Whichever comes first.
Intensive Care Unit (ICU) Mortality
ICU mortality rate
Time frame: Enrollment until ICU discharge, death, or 30-days. Whichever comes first.
Number of Participants With Delirium
Describes if patient has delirium as defined by the Confusion Assessment Method (CAM)-ICU. The CAM-ICU method requires that the patient have 3 features to qualify for delirium: 1. Acute Onset of Changes or Fluctuations in the Course of Mental Status (AND ) 2. Inattention (AND) 3. Disorganized thinking (OR) Altered Level of Consciousness
Time frame: On day 3 (at approximately 72 hours) after the first study drug dose
Hospital Disposition: Survivors Discharged Home
Home hospital disposition in patients who survive to discharge
Time frame: Enrollment until hospital discharge, death, or 30-days, whichever comes first.

Results

Posted Jan 29, 2021

Limitations and caveats

Ongoing or planned corticosteroid use was the most common exclusion criterion, perhaps eliminating a subset of patients more likely to benefit from corticosteroids. Some patients were discharged alive from the ICU within 96 hours of enrollment; thus, many patients did not receive a full 4 days of study drug

Participant flow

Participant flow — Overall Study
Milestone	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Started	103	102
Completed	101	99
Not completed	2	3
Withdrew: Protocol violation	1	3
Withdrew: Death	1	0

Outcome measures

PrimarySequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours. The SOFA score ranges from a minimum of 0 to a maximum of 24, with higher scores meaning worse outcomes.

Time frame:: Enrollment to 72-hours
Reported as:: Mean · Units on a scale

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours
Units on a scale	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Enrollment SOFA score	9.1 ± 3.5	9.2 ± 3.2
72 hour SOFA score	4.4 ± 4.1	5.1 ± 4.3

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Mixed Models Analysis · p = 0.12 (A priori threshold for significance, p-value \< 0.05) · Mean difference (net): -0.8 · 95% CI -1.7 to 0.2

SecondaryRenal Failure

Development of renal failure as defined by a Kidney Disease Improving Global Outcomes \[KDIGO\] stage 3 or higher. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output \< 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output \<0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy

Time frame:: Enrollment until 7-days or discharge from the ICU
Reported as:: Count of participants · Participants

Renal Failure
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Renal Failure	32	27

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Logistic · p = 0.58 · Risk difference (rd): 3.0 · 95% CI -10.0 to 20.0

Secondary30-day Mortality

Mortality rate

Time frame:: Enrollment until 30-days after enrollment
Reported as:: Count of participants · Participants

30-day Mortality
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
30-day Mortality	35	29

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Cox · p = 0.05 · Hazard ratio (hr): 1.3 · 95% CI 0.8 to 2.2

Other pre-specifiedVentilator Free Days

Days not receiving invasive mechanical ventilation

Time frame:: Ventilator free days over the first 7-days after enrollment
Reported as:: Median · Days

Ventilator Free Days
Days	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Ventilator Free Days	6 (2 to 7)	6 (0 to 7)

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Quantile Regression · p = >0.99 · Median difference (net): 0.0 · 95% CI -1.9 to 1.9

Other pre-specifiedShock Free Days

Days not receiving vasopressor

Time frame:: Vasopressor free days over the first 7-days after enrollment
Reported as:: Median · Days

Shock Free Days
Days	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Shock Free Days	5 (3 to 5)	4 (1 to 5)

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Quantile Regression · p = 0.02 · Median difference (net): 1.0 · 95% CI 0.2 to 1.8

Other pre-specifiedICU Free Days

Number of days that the patient was not in the ICU. Timeframe listed below.

Time frame:: From enrollment until 28 days after enrollment
Reported as:: Median · Days

ICU Free Days
Days	Vitamin C, Vitamin B1, Corticosteroids	Placebo
ICU Free Days	22 (3 to 25)	21 (4 to 25)

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Quantile Regression · p = 0.69 · Median difference (net): 1.0 · 95% CI -3.0 to 6.0

Other pre-specifiedHospital Mortality

Hospital mortality rate

Time frame:: Enrollment until hospital discharge, death, or 30-days. Whichever comes first.
Reported as:: Count of participants · Participants

Hospital Mortality
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Hospital Mortality	28	23

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Logistic · p = 0.55 · Risk difference (rd): 3.0 · 95% CI -10.0 to 20.0

Other pre-specifiedIntensive Care Unit (ICU) Mortality

ICU mortality rate

Time frame:: Enrollment until ICU discharge, death, or 30-days. Whichever comes first.
Reported as:: Count of participants · Participants

Intensive Care Unit (ICU) Mortality
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Intensive Care Unit (ICU) Mortality	23	20

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Logistic · p = 0.80 · Risk difference (rd): 2.0 · 95% CI -10.0 to 10.0

Other pre-specifiedNumber of Participants With Delirium

Describes if patient has delirium as defined by the Confusion Assessment Method (CAM)-ICU. The CAM-ICU method requires that the patient have 3 features to qualify for delirium: 1. Acute Onset of Changes or Fluctuations in the Course of Mental Status (AND ) 2. Inattention (AND) 3. Disorganized thinking (OR) Altered Level of Consciousness

Time frame:: On day 3 (at approximately 72 hours) after the first study drug dose
Reported as:: Count of participants · Participants

Number of Participants With Delirium
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Number of Participants With Delirium	31	35

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Logistic · p = 0.16 · Risk difference (rd): -12 · 95% CI -25 to 4

Other pre-specifiedHospital Disposition: Survivors Discharged Home

Home hospital disposition in patients who survive to discharge

Time frame:: Enrollment until hospital discharge, death, or 30-days, whichever comes first.
Reported as:: Count of participants · Participants

Hospital Disposition: Survivors Discharged Home
Participants	Vitamin C, Vitamin B1, Corticosteroids	Placebo
Hospital Disposition: Survivors Discharged Home	34	35

Statistical analysis

Vitamin C, Vitamin B1, Corticosteroids vs Placebo · Regression, Logistic · p = 0.82 · Risk difference (rd): -1.8 · 95% CI -18 to 14

Adverse events

Collected over Time from enrollment to hospital discharge, an average of 13.5 days for all patients. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Vitamin C, Vitamin B1, Corticosteroids	35/101 (34.7%)	13/101 (12.9%)	0/101 (0%)
Placebo	29/99 (29.3%)	12/99 (12.1%)	0/99 (0%)

Most frequent serious events

Most frequent serious events
Event	Vitamin C, Vitamin B1, Corticosteroids	Placebo
New Hospital Acquired InfectionInfections and infestations	13/101	12/99
HyperglycemiaEndocrine disorders	12/101	7/99
HypernatremiaMetabolism and nutrition disorders	11/101	7/99

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Mean	68.9 ± 15.0	67.7 ± 13.9	68.2 ± 14.5

Sex: Female, Male
Sex: Female, Male(Participants)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Female	44	45	89
Male	57	54	111

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
White	68	73	141
Black	18	16	34
Asian	5	3	8
More than one Race	0	1	1

BMI, mean (SD)
BMI, mean (SD)(kg/m^2)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Mean	28.8 ± 10.1	27.9 ± 8.4	28.3 ± 9.3

Medical History,
Medical History,(Participants)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
# with Malignancy	26	32	58
# with Coronary Artery Disease	26	26	52
# with Congestive Heart Failure	14	23	37
Liver Disease	11	7	18

Primary Infectious Source
Primary Infectious Source(Participants)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Pneumonia	31	28	59
Intra-abdominal	30	23	53
Urinary Tract Infection	20	22	42
Other	13	20	33

Volume of Intravenous Fluids Prior to Study Drug
Volume of Intravenous Fluids Prior to Study Drug(mL)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Median	2000 (1062 to 3000)	2000 (1125 to 3000)	2000 (1093.5 to 3000)

Time from Vasopressor Initiation to First Study Drug
Time from Vasopressor Initiation to First Study Drug(hours)	Vitamin C, Vitamin B1, Corticosteroids	Placebo	Total
Median	14.5 (8.1 to 19.1)	13.0 (7.5 to 20.5)	13.5 (8.0 to 19.8)

6 further baseline measures are reported on the registry.

Study locations

13 sites

Mayo Clinic - Arizona
Phoenix, Arizona 85054, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Mount Auburn Hospital
Cambridge, Massachusetts 02138, United States
Detroit Receiving Hospital
Detroit, Michigan 48201, United States
Harper University Hospital
Detroit, Michigan 48201, United States
Henry Ford Hospital
Detroit, Michigan 48202, United States
Sinai Grace Hospital
Detroit, Michigan 48235, United States
Beaumont Hospital
Royal Oak, Michigan 48073, United States
North Shore University Hospital
Manhasset, New York 11030, United States
Long Island Jewish Hospital
New York, New York 11040, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
The University of Texas Health Science Center
Houston, Texas 77030, United States

References and documents

Publications

Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6. PubMed 27940189 ↗
Moskowitz A, Andersen LW, Cocchi MN, Karlsson M, Patel PV, Donnino MW. Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2017 May;14(5):737-741. doi: 10.1513/AnnalsATS.201608-656BC. PubMed 28207287 ↗
Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572. PubMed 26771781 ↗
Grossestreuer AV, Moskowitz A, Andersen LW, Holmberg MJ, Konacki V, Berg KM, Chase M, Cocchi MN, Donnino MW. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis. Crit Care Explor. 2020 Nov 23;2(12):e0270. doi: 10.1097/CCE.0000000000000270. eCollection 2020 Dec. PubMed 33251516 ↗
Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW; ACTS Clinical Trial Investigators. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):642-650. doi: 10.1001/jama.2020.11946. PubMed 32809003 ↗
Moskowitz A, Yankama T, Andersen LW, Huang DT, Donnino MW, Grossestreuer AV; ACTS Clinical Trial Investigators. Ascorbic Acid, Corticosteroids and Thiamine in Sepsis (ACTS) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomised, placebo-controlled clinical trial. BMJ Open. 2019 Dec 17;9(12):e034406. doi: 10.1136/bmjopen-2019-034406. PubMed 31852712 ↗

Study documents

Study protocol ↗ · Dec 13, 2018
Statistical analysis plan ↗ · Dec 13, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Nov 2019, 21 months.

Results were first posted in Jan 2021, 1 year 2 months after primary completion.

Of 13 phase 2/3 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 27, 2017
First posted: Jan 3, 2018
StartActual: Feb 9, 2018
Primary completionActual: Nov 26, 2019
CompletionActual: Feb 28, 2020
Results first posted: Jan 29, 2021
Last update: Feb 16, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03389555
Lead sponsor: Beth Israel Deaconess Medical Center
Collaborators: Open Philanthropy
Responsible party: Michael Donnino (Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted: Jan 3, 2018
Start date: Feb 9, 2018
Primary completion: Nov 26, 2019
Completion: Feb 28, 2020
Results posted: Jan 29, 2021
Last update: Feb 16, 2021

Study contacts

Michael W Donnino, MD

principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Ascorbic Acid · Thiamine · Hydrocortisone

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Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

Study summary

Conditions studied

Browse trials for

Keywords

In context

Shock, Septic Reclassified

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Timeline

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria