CClinicalTrials.gg
Status unknownNCT05049941Updated Sep 20, 2021

Blood Gases Versus Lactate Clearance as an Indicator of Initial Resuscitation in Septic Patients: Comparative Study

An observational study in Sepsis Syndrome, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-20.

Sponsored by Minia University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study summary

  • This perspective blind randomized single center study was designed to assess central venous and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against lactate clearance as an indicator of initial resuscitation in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol .this continuation of our previous work we compared the ratio of P(v-a)CO2/C(a-v)O2 ratio against lactate clearance(8). Mortality in the ICU in the study groups will be recorded
Read the detailed description

On ICU admission, Criteria of Systemic Inflammatory Response Criteria (SIRS) were evaluated including: abnormal white blood cell count >12,000/ μL or \<4000/ μL, heart rate >90/min, respiratory rate >20/min or PaCO2 \< 32 mmHg or abnormal body temperature >38.3 °C (100.4 °F) or \<36 °C (96.8 °F). The quick Sequential Organ Failure assessment (qSOFA) score (10) measured at the bedside : altered level of consciousness (Glasgow Coma Scale score ≤ 13), Systolic blood pressure \< 90 mmHg and respiratory rate ≥ 22 rpm. The Acute Physiology and Chronic Health Evaluation (APACHE II) score were collected (Knaus et al.,1985). Patients monitoring of heart rate, pulse oximetry, invasive arterial blood pressure for measurement of MAP, core temperature (UltraviewSL2700; Spacelaps, USA). and urine output. Laboratory investigations includes: complete blood count, C-reactive protein, liver and renal functions, coagulation profile, blood glucose, sodium and potassium level. All patients had jugular central venous catheter was inserted under ultrasound guidance, and the position confirmed by chest radiograph, then central venous pressure (CVP) was measured before starting the initial resuscitation (T0) ansd 8 hours after resuscitation (T8). From CVP line, blood sample analyzed by (SIEMENS RAPIDPoint® 500 blood gas machine). The following measurements were recorded at (T0) and at (T8): Central venous oxygen saturation (ScvO2), Central venous oxygen tension (Pvo2) and Central venous carbon dioxide tension (Pvco2). The central venous oxygen content (Cvo2) Cvo2 = (1.34 × Svo2 × Hb) + (0.003 × Pvo2) Radial arterial canula was inserted under ultrasound guidance to all patients and arterial blood gases (ABG) was analyzed at (T0) and (T8) to measure: arterial oxygen tension (Pao2), arterial oxygen content (Cao2), arterial carbon dioxide tension (Paco2), arterial oxygen saturation (Sao2.) and lactate level Cao2 = (1.34 × Sao2 × Hb) + (0.003 × Pao2) Resuscitation Patients were randomly assigned (by computer generated sequence) into three groups each consists of 40 patients: Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group; Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%.

Group (3):

veno-arterial carbon dioxide tension group; P(v-a)co2 difference Measurements were obtained at T0 (before the start of resuscitation) and at T8 (after 8 hours of the start of resuscitation), the three groups received the same initial resuscitation protocol according to Surviving Sepsis Campaign (9), the appropriate specimens were taken for aerobic and anaerobic culture, empirical broad-spectrum antibiotics was given, source of infection was controlled with removal of any old intravascular lines which may be the source of sepsis.

The early goals of resuscitation were to achieve the following: CVP of 8-12 cmH2O, MAP > 65 mm Hg, a urine output >0.5 mL/kg and Scvo2 of 70% or more, we started with 30 ml/kg crystalloids in the first 3 hours, then we guided by hemodynamic status, if not achieved, we were targeted by titrating vasopressors until MAP > 65 mmHg by using either norepinephrine (0.25 mcg /kg/min increasing every 15 min) or dobutamine (2.5 mcg/min every 15 min increased). The patients connected to mechanical ventilation if needed with appropriate settings, with minimal dose of sedation, blood glucose controlled and anticoagulant and Proton pump inhibitors were administrated as a prophylaxis, early enteral nutrition was initiated, if there was no contraindications Measured data

In group (1) we prepared this measures at T0 and T8:

  • The arteriovenous oxygen content difference (C(a-v)O2) C(a-v)O2 = Cao2 - Cvo2
  • The venoarterial CO2 tension difference (P(v-a)CO2) P(v-a)CO2 = Pvco2 - Paco2
  • P(v-a)CO2/C(a-v)O2 ratio

    • (Pvco2 - Paco2)/(Cao2 - Cvo2)
02

Conditions studied

03

In context

Toxemia

936 studies on the registry are indexed under Toxemia; 155 are open to participants now.

This study's planned enrollment of 120 is below the median of 144 across 460 observational studies indexed under Toxemia.

Browse Toxemia studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

120 adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016

Inclusion criteria

adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016

Exclusion criteria

Exclusion Criteria:

  • We excluded Patients with chronic organ failure (Cardiovascular, Respiratory, Liver, Neurological and Renal.)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • group1

    Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group.

    Diagnostic Test: lactat and blood gases

  • group 2

    Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation \[(lactate(T0)- lactate(T8))/lactate(T0)\] × 100%.

    Diagnostic Test: lactat and blood gases

  • group 3

    Group (3): veno-arterial carbon dioxide tension group; P(v-a)co2 difference

    Diagnostic Test: lactat and blood gases

Interventions

  • Diagnostic testlactat and blood gases

    observational

06

What researchers measure

Primary outcomes

  1. in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol

    success of early resuscitation

    Time frame: 3-4 monthes

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05049941
Lead sponsor
Minia University
Responsible party
Ahmed Hassanein Mohamed (assistant professor, Minia University) — Principal investigator
First posted
Sep 20, 2021
Start date
Aug 15, 2021
Primary completion
Nov 15, 2021 (estimated)
Completion
Dec 15, 2021 (estimated)
Last update
Sep 20, 2021

Study contacts

ahmed hassanein, MD
Contact
ahmedhassanein10@yahoo.com
01006946879
rehab mohamed, MD
Contact
rehabmahamed820@gmail.com
01004407515
ahmed hassanein, MD
principal investigator · Minia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion