Thiamine as a Renal Protective Agent in Septic Shock

Browse trials for

• Sepsis 2,416
• Thiamine Deficiency 18

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's enrollment of 95 is close to the median of 102 across 1,165 interventional studies indexed under Sepsis.

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.

Study arms

• Experimental
  Thiamine

  200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)

  Drug: Thiamine Hydrochloride

• Placebo comparator
  Placebo

  Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)

  Drug: Placebo

Interventions

• DrugThiamine Hydrochloride

  Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.

  Also known as: Thiamine, Vitamin B1

• DrugPlacebo

  50ml of 0.9% NACL will serve as the placebo

  Also known as: Normal Saline, 0.9%NACL

Primary outcomes

1. Kidney Injury Biomarker

   Change in creatinine over time

   Time frame: Enrollment to 72-hours

Secondary outcomes

1. Number of Participants Receiving Renal Replacement Therapy

   Number of participants who received renal replacement therapy in thiamine and placebo groups.

   Time frame: From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment

2. ICU Free Days

   Days alive and free of the ICU through day 28

   Time frame: From date of enrollment until 28 days after enrollment

3. In-hospital Mortality

   Length of hospital stay truncated at 60 days

   Time frame: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment

4. Number of Participants Experiences Acute Renal Failure

   Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, \<0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).

   Time frame: From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment

5. Change in Lactate Level

   Change in lactate level between enrollment and 72 hours after enrollment

   Time frame: From time of enrollment until 72 hours after enrollment

6. Number of Participants With Delirium on Day 3

   Number of Participants with Delirium on Day 3 after enrollment

   Time frame: Day 3 after enrollment

7. Change in the Sequential Organ Failure Assessment Score

   Change in Sequential Organ Failure Assessment Score (SOFA) score between enrollment and 72 hours after enrollment. SOFA scores are reported on a scale between 0-24, with 0 representing best outcome and 24 representing worst outcome.

   Time frame: Time of enrollment until 72 hours after enrollment

8. Novel Biomarkers of Renal Injury

   KIM-1, NGAL, Cystatin-C at 24-hours after enrollment

   Time frame: 24 hours after enrollment

Baseline characteristics

9 further baseline measures are reported on the registry.

Publications

• 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 ↗

Study documents

• Study protocol ↗ · Jul 2, 2021
• Statistical analysis plan ↗ · Jun 15, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided