NCT05049941

Brief Summary

\- This perspective blind randomized single center study was designed to assess central venous and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against lactate clearance as an indicator of initial resuscitation in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol .this continuation of our previous work we compared the ratio of P(v-a)CO2/C(a-v)O2 ratio against lactate clearance(8). Mortality in the ICU in the study groups will be recorded

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 15, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 9, 2021

Last Update Submit

September 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol

    success of early resuscitation

    3-4 monthes

Study Arms (3)

group1

Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group.

Diagnostic Test: lactat and blood gases

group 2

Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation \[(lactate(T0)- lactate(T8))/lactate(T0)\] × 100%.

Diagnostic Test: lactat and blood gases

group 3

Group (3): veno-arterial carbon dioxide tension group; P(v-a)co2 difference

Diagnostic Test: lactat and blood gases

Interventions

lactat and blood gasesDIAGNOSTIC_TEST

observational

group 2group 3group1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

120 adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016

You may qualify if:

  • adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016

You may not qualify if:

  • We excluded Patients with chronic organ failure (Cardiovascular, Respiratory, Liver, Neurological and Renal.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Hassanein

Minya, 11116, Egypt

RECRUITING

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • ahmed hassanein, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed hassanein, MD

CONTACT

rehab mohamed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

August 15, 2021

Primary Completion

November 15, 2021

Study Completion

December 15, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09

Locations