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

ConditionsPolytraumaResuscitation, Trauma Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPakistan Institute of Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Either Gender

Poly-trauma patients

Both surgical and non-surgical

Shock States

Disqualifiers

Any Chest trauma

Patients with Obstructive and restrictive lung disease

Obstructive sleep apnea

Septic shock

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Carbondioxide gap groupExperimental treatment 1 intervention
Group B: Conventional resuscitation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of mechanical ventilation

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

Secondary outcomes

1

ICU stay

Time frame
This will the total length of ICU stay measured in number of days
2

ICU Mortality

Time frame
This will be the death occurring during ICU stay
3

qSOFA score

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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