PolytraumaPhase 4NCT07480655
Pv-aCO₂ Gap-Guided Resuscitation in Adult Polytrauma Patients: A Prospective Randomized Controlled Trial
A Phase 4 study testing Veno-arterial Carbondioxide gap and Conventional resuscitation end points in people with Polytrauma and Resuscitation, Trauma Patients, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polytrauma, Resuscitation, Trauma Patients
- What is being tested?
- Veno-arterial Carbondioxide gap and Conventional resuscitation end points
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Mar 2026to 16 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either Gender
- Poly-trauma patients
- ○ Both penetrating and blunt trauma
- Both surgical and non-surgical
- Shock States
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Anesthesia, Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
Naheed Fatima, MBBS,FCPS, +92-300-5236655, naheedfk73@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Polytrauma, Resuscitation, Trauma Patients
- Being tested
- Veno-arterial Carbondioxide gap, Conventional resuscitation end points
- Keywords
- Veno-arterial carbondioxide gap, Polytrauma resuscitation
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veno-arterial Carbondioxide gapDiagnostic 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.
Conventional resuscitation end pointsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Carbondioxide gap group | Experimental | Not described Receives: Diagnostic Test: Veno-arterial Carbondioxide gap |
| Conventional resuscitation group | Active comparator | Not described Receives: Diagnostic Test: Conventional resuscitation end points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation
Measured: This will be the number of days of ventilatory support once patient is admitted to ICU
Secondary outcomes (3)
ICU stay
Measured: This will the total length of ICU stay measured in number of days
ICU Mortality
Measured: This will be the death occurring during ICU stay
qSOFA score
Measured: This will be measured at time of admission in ICU then at 48h and 72h following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480655
- Sponsor's protocol ID
- F5.2/2024(ERRC)/PIMS
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital Ethical committee doesnt allow data sharing
Publications
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.
PubMed 34001982
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07480655
- Acronym / sponsor ID
- F5.2/2024(ERRC)/PIMS
- Conditions
- Polytrauma, Resuscitation, Trauma Patients
- Keywords
- Veno-arterial carbondioxide gap, Polytrauma resuscitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbondioxide gap group | Experimental | Diagnostic Test: Veno-arterial Carbondioxide gap |
| Conventional resuscitation group | Active comparator | Diagnostic Test: Conventional resuscitation end points |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Either Gender
- Poly-trauma patients
- ○ Both penetrating and blunt trauma
- Both surgical and non-surgical
- Shock States
Key exclusion criteria (7 listed)
- Any Chest trauma
- Patients with Obstructive and restrictive lung disease
- Obstructive sleep apnea
- Septic shock
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veno-arterial Carbondioxide gapArterial 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. | Diagnostic test | Carbondioxide gap group |
| Conventional resuscitation end pointsPatients 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. | Diagnostic test | Conventional resuscitation group |
Primary outcome
Length of mechanical ventilation
Time frame: This will be the number of days of ventilatory support once patient is admitted to ICU
3 secondary outcomes
ICU stay
Time frame: 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
qSOFA score
Time frame: This will be measured at time of admission in ICU then at 48h and 72h following admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 34001982Doppmann 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.
- Individual participant dataSharing planned: No. Hospital Ethical committee doesnt allow data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Veno-arterial Carbondioxide gap and Conventional resuscitation end points in people with Polytrauma and Resuscitation, Trauma Patients, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haroon Anwar, MBBS (+92-333-5236956, haroonanwar22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of mechanical ventilation (time frame: This will be the number of days of ventilatory support once patient is admitted to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07480655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.