ClinicalTrials.gg
Status unknownNCT03374579co2gapUpdated Mar 29, 2018

co2 Gap and co2/o2 Ratio in Liver Transplant Patients

An interventional study of Fluid challenge in Liver Transplantation, sponsored by Kasr El Aini Hospital. Status unknown at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Liver Transplantation
03

In context

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 283 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age less than 18 years
  • patients with fulminant liver failure.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CO2 gap

    The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them.

    Diagnostic Test: Fluid challenge

Interventions

  • Diagnostic testFluid challenge

    Fluid challenge and measure change in co2 gap

06

What researchers measure

Primary outcomes

  1. co2gap

    Difference between arterial and venous co2 gap

    Time frame: 30 minuets after fluid bolus

Secondary outcomes

  1. Stroke volume

    Stroke volume assessed by cardiometry

    Time frame: Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2017 (actual). Primary completion is estimated for May 2018, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Dec 15, 2017
StartActual
Jun 12, 2017
Primary completionEst.
May 12, 2018
CompletionEst.
Sep 12, 2018
Last update
Mar 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03374579
Responsible party
Ahmed Mukhtar (Professor, Kasr El Aini Hospital) — Principal investigator
First posted
Dec 15, 2017
Start date
Jun 12, 2017
Primary completion
May 12, 2018 (estimated)
Completion
Sep 12, 2018 (estimated)
Last update
Mar 29, 2018

Study contacts

Ahmed m Mukhtar, Professor
Contact
Ahmed.mukhtar@kasralainy.edu.eg
+0220111420844
Hassan kh Nagi, Professor
Contact
hknagi@hotmail.com
01223634792
Ahmed m Mukhtar, professor
principal investigator · kasrelainy medical school,cairo university,cairo,egypt
Hassan kh Nagi, professor
study chair · kasrelainy medical school,cairo university,cairo,egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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