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Completed

NCT Number: NCT04792242

Effect of PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries

1. Primary (main):

Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative 2. Secondary (subsidiary):

Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University

Luxor, Qena Governorate, 83523, Egypt

About this study

High risk surgical participants in South valley university hospitals (teaching hospitals) who will undergo major abdominal surgeries will be included in research after giving written informed consent from the participants or from the patient's legal representative. The use of obtained data will be approved by local ethics committee.

All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.

the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).

Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) > 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) >75% and urine output more than >0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).

All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.

Outcomes in both groups will be recorded which will be number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay, 30 days organ dysfunction, assessed by using the Sequential Organ Failure Assessment (SOFA) and 30 days mortality .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues

Exclusion criteria

  • patients who will refuse to continue on research patients who will not be admitted post operative in the ICU

Treatment and study plan

cv line insertion

Device

Svo2 and central venous pressure measurements

Urinary catheter insertion

Device

urine output measurement

Arterial line

Device

Arterial blood gases measurment

Primary outcomes

  1. Post operative mortality

    Time frame: 30 days

    early post operative mortality

Secondary outcomes

  1. post operative organ failure

    Time frame: 30 days

    cardiac,renal,respiratory,renal central nervous system(CNS) failure by sequential organ failure(SOFA) score

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Comparison Between Goal Directed Therapy and PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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