co2 Gap and co2/o2 Ratio in Liver Transplant Patients | NCT03374579

Studies
co2 Gap and co2/o2 Ratio in Liver Transplant Patients

NCT03374579

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Mar 29, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Liver Transplantation

Interventions

Fluid challenge

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2017Actual

Primary Completion Date

May 12, 2018Estimated

Completion Date

Sep 12, 2018Estimated

First Submitted Date

Dec 11, 2017

First Submission Date that Met QC Criteria

Dec 14, 2017

First Posted Date

Dec 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2018

Last Update Posted Date

Mar 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CO2 gap	Experimental	The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them.	Diagnostic Test: Fluid challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluid challenge	Diagnostic Test	Fluid challenge and measure change in co2 gap	CO2 gap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
co2gap	Difference between arterial and venous co2 gap	30 minuets after fluid bolus

Secondary Outcomes

Measure	Description	Time Frame
Stroke volume	Stroke volume assessed by cardiometry	Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients post liver transplantation
serum lactate >2mmol/L

Exclusion Criteria:

age less than 18 years
patients with fulminant liver failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed m Mukhtar, Professor	Contact	+0220111420844		Ahmed.mukhtar@kasralainy.edu.eg
Hassan kh Nagi, Professor	Contact	01223634792		hknagi@hotmail.com

Overall Officials

Name	Affiliation	Role
Ahmed m Mukhtar, professor	kasrelainy medical school,cairo university,cairo,egypt	Principal Investigator
Hassan kh Nagi, professor	kasrelainy medical school,cairo university,cairo,egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University Medical School	Recruiting	Cairo		11511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided