- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03374579
co2 Gap and co2/o2 Ratio in Liver Transplant Patients (co2gap)
Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%.
Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed m Mukhtar, Professor
- Phone Number: +0220111420844
- Email: Ahmed.mukhtar@kasralainy.edu.eg
Study Contact Backup
- Name: Hassan kh Nagi, Professor
- Phone Number: 01223634792
- Email: hknagi@hotmail.com
Study Locations
-
-
-
Cairo, Egypt, 11511
- Recruiting
- Cairo university medical school
-
Contact:
- Ahmed m Mukhtar, professor
- Phone Number: 002 01114208444
- Email: ahmed.mukhtar@kasralainy.edu.eg
-
Contact:
- Hassan kh Nagy, professor
- Phone Number: 002 01223634792
- Email: hknagi@hotmail.com
-
Cairo, Egypt, 11562
- Recruiting
- Kasralainy Hospital
-
Contact:
- Ahmed Mukhtar, Professor
- Phone Number: 01114208444
- Email: Ahmed.mukhtar@kasralainy.edu.eg
-
Contact:
- Hassan Khaled, Professor
- Phone Number: 01223634792
- Email: hknagi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients post liver transplantation
- serum lactate >2mmol/L
Exclusion Criteria:
- age less than 18 years
- patients with fulminant liver failure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CO2 gap
The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them.
|
Fluid challenge and measure change in co2 gap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
co2gap
Time Frame: 30 minuets after fluid bolus
|
Difference between arterial and venous co2 gap
|
30 minuets after fluid bolus
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke volume
Time Frame: Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus
|
Stroke volume assessed by cardiometry
|
Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed m Mukhtar, professor, kasrelainy medical school,cairo university,cairo,egypt
- Study Chair: Hassan kh Nagi, professor, kasrelainy medical school,cairo university,cairo,egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N-60-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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