NCT03374579

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

December 11, 2017

Last Update Submit

March 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • co2gap

    Difference between arterial and venous co2 gap

    30 minuets after fluid bolus

Secondary Outcomes (1)

  • Stroke volume

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

Study Arms (1)

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

Fluid challengeDIAGNOSTIC_TEST

Fluid challenge and measure change in co2 gap

CO2 gap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University Medical School

Cairo, 11511, Egypt

RECRUITING

Kasralainy hospital

Cairo, 11562, Egypt

RECRUITING

Study Officials

  • 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

Central Study Contacts

Ahmed m Mukhtar, Professor

CONTACT

Hassan kh Nagi, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Fluid challenge with assessment of change of co2 gap
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 15, 2017

Study Start

June 12, 2017

Primary Completion

May 12, 2018

Study Completion

September 12, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations