Pv-aCO₂ Gap-Guided Resuscitation in Adult Polytrauma Patients: A Prospective Randomized Controlled Trial

NCT07480655 | Recruiting Phase 4 DMC

• 1 other identifier: F5.2/2024(ERRC)/PIMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

dult patients with multiple traumatic injuries admitted to the ICU from the operating room, emergency department, or hospital wards who meet the study criteria will be included after obtaining informed consent from the patient or their legal guardian. Participants will be randomly divided into two groups: one group will receive treatment guided by the difference between carbon dioxide levels in venous and arterial blood, while the other group will receive treatment based on standard resuscitation parameters commonly used in critical care. As part of routine monitoring, all patients will have a central venous catheter and an arterial line inserted to measure blood parameters. Blood samples from both lines will be taken shortly after ICU admission and at regular intervals during the first three days. These samples will be analyzed using a bedside blood gas machine, and the results will be compared between the two groups to determine whether monitoring the difference in carbon dioxide levels between venous and arterial blood improves patient outcomes compared with standard care.

Conditions

Polytrauma; Resuscitation, Trauma Patients

Keywords

Veno-arterial carbondioxide gap; Polytrauma resuscitation

Outcome Measures

Primary Outcomes (1)

• Length of mechanical ventilation

  This will be the number of days of ventilatory support once patient is admitted to ICU

Secondary Outcomes (3)

• ICU stay

  This will the total length of ICU stay measured in number of days

• ICU Mortality

  This will be the death occurring during ICU stay

• qSOFA score

  This will be measured at time of admission in ICU then at 48h and 72h following admission

Study Arms (2)

Carbondioxide gap group

EXPERIMENTAL

Diagnostic Test: Veno-arterial Carbondioxide gap

Conventional resuscitation group

ACTIVE COMPARATOR

Diagnostic Test: Conventional resuscitation end points

Interventions

Veno-arterial Carbondioxide gap DIAGNOSTIC_TEST

Arterial and central venous blood samples will be obtained for blood gas analysis using a point-of-care blood gas analyzer (ABL800 FLEX®, Radiometer). Sampling will be performed within 1 hour of ICU admission and subsequently at 6, 12, 24, 48, and 72 hours during the ICU stay. The measurements will be used to assess arterial and venous blood gas parameters for monitoring and guiding patient management.

Carbondioxide gap group

Conventional resuscitation end points DIAGNOSTIC_TEST

Patients in this group will be managed using standard resuscitation parameters, including monitoring of arterial base deficit, arterial pH, serum lactate levels, and bicarbonate levels. These parameters will be measured through arterial blood gas analysis within 1 hour of admission to the ICU and subsequently at 6, 12, 24, 48, and 72 hours during the ICU stay, and will be used to guide ongoing resuscitation and clinical management.

Conventional resuscitation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either Gender
• Poly-trauma patients
• ○ Both penetrating and blunt trauma
• Both surgical and non-surgical
• Shock States

You may not qualify if:

• Any Chest trauma
• Patients with Obstructive and restrictive lung disease
• Obstructive sleep apnea
• Septic shock
• Pregnant patients
• Patients who will require readmission within 48 h after step-down from the ICU.
• Patients who will need extra-corporeal membrane oxygenation support

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Department of Anesthesia, Pakistan Institute of Medical Sciences

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Doppmann P, Meuli L, Sollid SJM, Filipovic M, Knapp J, Exadaktylos A, Albrecht R, Pietsch U. End-tidal to arterial carbon dioxide gradient is associated with increased mortality in patients with traumatic brain injury: a retrospective observational study. Sci Rep. 2021 May 17;11(1):10391. doi: 10.1038/s41598-021-89913-x.

  PMID: 34001982 BACKGROUND

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Muhammad Haroon Anwar, MBBS

CONTACT

+92-333-5236956; haroonanwar22@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 18, 2026
• Study Start: March 16, 2026
• Primary Completion: June 16, 2026
• Study Completion: June 16, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)