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

March 15, 2026 updated by: Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences

Evaluation of Effect of Pv-aCO2-Gap on Clinical Outcomes With Standard Resuscitation End-points in Adult Poly-trauma Patients Admitted to the ICU --- Prospective Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All polytrauma patients admitted to the ICU from the operating theater, emergency department, or hospital wards who fulfill the inclusion criteria will be enrolled in the study after obtaining written informed consent from the patients or their legal representatives. Participants will be randomized in a 1:1 ratio using a computer-generated method into two groups: an intervention group managed with a Pv-aCO₂ gap-targeted approach and a control group managed according to standard resuscitation end-points. As part of routine hemodynamic monitoring in critical care, a central venous catheter (two- or three-lumen catheter-Arrow) and an arterial catheter (Arterial Leader Cath-Vygon or Teleflex) will be inserted in all participants before or immediately after ICU admission. After insertion, the position of the central venous catheter tip at the junction of the superior vena cava and right atrium will be confirmed by chest X-ray. Arterial and venous blood samples for blood gas analysis (ABGA and VBGA) will be obtained in the ICU using a point-of-care gas analyzer (ABL800 FLEX®, Radiometer) within 1 hour of ICU admission and subsequently at 6, 12, 24, 48, and 72 hours. The time interval between arterial and venous blood sampling will be kept under 5 minutes to minimize bias, and the measurements obtained at different time points will be compared with standard resuscitation end-points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Recruiting
        • Department of Anesthesia, Pakistan Institute of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Either Gender

  • Poly-trauma patients

    ○ Both penetrating and blunt trauma

  • Both surgical and non-surgical
  • Shock States

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carbondioxide gap group
Diagnostic test: Veno-arterial Carbondioxide gap
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.
Active Comparator: Conventional resuscitation group
Diagnostic test: Conventional resuscitation end points
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Length of mechanical ventilation
Time Frame: This will be the number of days of ventilatory support once patient is admitted to ICU
This will be the number of days of ventilatory support once patient is admitted to ICU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
ICU stay
Time Frame: This will the total length of ICU stay measured in number of days
This will the total length of ICU stay measured in number of days
ICU Mortality
Time Frame: This will be the death occurring during ICU stay
This will be the death occurring during ICU stay
qSOFA score
Time Frame: This will be measured at time of admission in ICU then at 48h and 72h following admission
This will be measured at time of admission in ICU then at 48h and 72h following admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F5.2/2024(ERRC)/PIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hospital Ethical committee doesnt allow data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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