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Trial record 11 of 2528 for:    CARBON DIOXIDE

co2 Gap and co2/o2 Ratio in Liver Transplant Patients (co2gap)

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ClinicalTrials.gov Identifier: NCT03374579
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mukhtar, Kasr El Aini Hospital

Brief Summary:
finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .

Condition or disease Intervention/treatment Phase
Liver Transplantation Diagnostic Test: Fluid challenge Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Fluid challenge with assessment of change of co2 gap
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : May 12, 2018
Estimated Study Completion Date : September 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO2 gap
The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them.
Diagnostic Test: Fluid challenge
Fluid challenge and measure change in co2 gap




Primary Outcome Measures :
  1. co2gap [ Time Frame: 30 minuets after fluid bolus ]
    Difference between arterial and venous co2 gap


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients post liver transplantation
  • serum lactate >2mmol/L

Exclusion Criteria:

  • age less than 18 years
  • patients with fulminant liver failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374579


Contacts
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Contact: Ahmed m Mukhtar, Professor +0220111420844 Ahmed.mukhtar@kasralainy.edu.eg
Contact: Hassan kh Nagi, Professor 01223634792 hknagi@hotmail.com

Locations
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Egypt
Cairo University Medical School Recruiting
Cairo, Egypt, 11511
Contact: Ahmed m Mukhtar, professor    01114208444 ext 002    ahmed.mukhtar@kasralainy.edu.eg   
Contact: Hassan kh Nagy, professor    01223634792 ext 002    hknagi@hotmail.com   
Kasralainy hospital Recruiting
Cairo, Egypt, 11562
Contact: Ahmed Mukhtar, Professor    01114208444    Ahmed.mukhtar@kasralainy.edu.eg   
Contact: Hassan Khaled, Professor    01223634792    hknagi@hotmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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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

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Responsible Party: Ahmed Mukhtar, Professor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03374579     History of Changes
Other Study ID Numbers: N-60-2017
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No