NCT05679778

Brief Summary

  1. 1.To assess validity of of central and pulmonary veno - arterial CO2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation.
  2. 2.comparison between PCO2 gab and left ventricular outflow tract velocity time integral to determine whether to continue or stop resuscitation and whether PCO2 gab is a surrogate of cardiac output or not.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

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

First Submitted

Initial submission to the registry

December 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 24, 2022

Last Update Submit

December 24, 2022

Conditions

Keywords

Delta PCO2 gapEchocardiographyLeft ventricle outflow tract velocity

Outcome Measures

Primary Outcomes (1)

  • Improvement of heamodynamic state, need of fluid resuscitation and inotropes.

    Assessing need of fluid resuscitation and need of inotropes to continue resuscitation to maintain stable heamodynamic status.

    January 2023 to January 2024

Secondary Outcomes (1)

  • Duration of hospital stay, time to control various clinical and laboratory abnormalities (BP, PP, RR, lactate, renal chemistry) and development of complications as; pulmonary edema and use of mechanical ventilation.

    January 2023 to January 2024

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All critical ill-patients of all age groups, who presented shocked, with good echocardiographic window, with CVC insertion.

You may qualify if:

  • all critical ill-patients with acute physiological assessment and chronic health evaluation II score (APACHE II score)≥25 with central line insertion, in the critical care uint of internal medicine department of Assuit university hospital in the period between January 2023 to January 2024.

You may not qualify if:

  • Pateints with poor echocardiographic window.
  • Pateints with APACHE II score \< 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gavelli F, Teboul JL, Monnet X. How can CO2-derived indices guide resuscitation in critically ill patients? J Thorac Dis. 2019 Jul;11(Suppl 11):S1528-S1537. doi: 10.21037/jtd.2019.07.10.

    PMID: 31388457BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khaled Ali

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MMAELGHANY

Study Record Dates

First Submitted

December 24, 2022

First Posted

January 11, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 30, 2024

Last Updated

January 11, 2023

Record last verified: 2022-12