A Phase 4 interventional study of Veno-arterial Carbondioxide gap and Conventional resuscitation end points in Polytrauma and Resuscitation, Trauma Patients, sponsored by Pakistan Institute of Medical Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Pakistan Institute of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's planned enrollment of 60 is below the median of 94 across 50 interventional studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Pakistan Institute of Medical Sciences is the lead sponsor of 55 studies on the registry; 25 are open to participants now.
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Poly-trauma patients
○ Both penetrating and blunt trauma
Exclusion Criteria:
Diagnostic Test: Veno-arterial Carbondioxide gap
Diagnostic Test: Conventional resuscitation end points
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.
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.
Length of mechanical ventilation
Time frame: This will be the number of days of ventilatory support once patient is admitted to ICU
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
Plan to share: No — Hospital Ethical committee doesnt allow data sharing
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Pakistan Institute of Medical Sciences