Role of PCO2 Gap as Predictor of Clinical Outcome in ICU Septic Patients (PCO2)

February 10, 2024 updated by: Ahmed wagih Ezzat deusouky, Ain Shams University

Comparison Between PCO2 Gap, Lactate and Procalcitonin as Predictors of Clinical Outcome in ICU Septic Patients

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management.

This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery and affect hundreds of millions of patients worldwide every year The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis. Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen-derived parameters during the early phases of resuscitation in septic shock.

Blood lactate level is also useful in evaluating sepsis. Serum lactate is a good indicator of the presence of hypoxic tissue during septic shock, since its production takes place during Anerobic metabolism.

Procalcitonin (PCT) is the precursor of calcitonin, and higher levels are associated with the development of sepsis. Com¬monly, there is an elevation of PCT levels 4 h after the on¬set of symptoms, peaking between 8 h and 24 h.

Study Type

Observational

Enrollment (Estimated)

80

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

  • Name: Ahmed El-Dolah, lecturer of Anesthesia
  • Phone Number: +20111113077
  • Email: a_wagih82@yahoo.com

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients admitted in ICU departments with sepsis

Description

Inclusion Criteria:

  • Adult septic patients ≥ 21 years old

Exclusion Criteria:

  • Patients with history of chronic obstructive pulmonary disease and bronchial asthma.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group S
survivors
Other: measurement of serum lactate and procalcitonin and PCO2 gap
measurement of serum lactate, procalcitonin and PCO2 gap
Group M
non survivors
Other: measurement of serum lactate and procalcitonin and PCO2 gap
measurement of serum lactate, procalcitonin and PCO2 gap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of clinical outcome in ICU septic patients
Time Frame: 48 hours
PCO2 gap mmHg will be measured on admission and after 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

February 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MS 719/2022

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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