NCT06242561

Brief Summary

This is a single-center retrospective study conducted at Mercy hospital, aiming to investigate the correlation between changes in hemoglobin (Hb) levels and the volume of vascular refill administered during the first 48 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

January 5, 2024

Last Update Submit

August 8, 2024

Conditions

Sepsis

Keywords

hemoglobin levels

Outcome Measures

Primary Outcomes (1)

  • Total volume of fluids administered during the first 48 hours of ICU stay

    Total volume of fluids (ml)

    48 hours from ICU admission

Secondary Outcomes (5)

  • Haemoglobinemia

    48 hours from ICU admission

  • Type of fluids administered during the first 48 hours of ICU stay

    48 hours from ICU admission

  • Volume of fluids administered before admission in ICU (ml)

    at ICU admission

  • In hospital mortality

    at hospital discharge : an average of 15 days

  • Length of hospital stay

    at hospital discharge : an average of 15 days

Interventions

Data collection from sepsis managementBEHAVIORAL

observational study

Eligibility Criteria

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

Septic patients

You may qualify if:

  • Patients with septic shock, admitted to Mercy hospital between November 1, 2022 and July 31, 2023, with Noradrenaline administration for at least 6 hours and at least 2 hemoglobin measurements during the first 48 hours of resuscitation.

You may not qualify if:

  • patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Damien BARRAUD, MD

    CHR Metz Thionville Hopital Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2024

First Posted

February 5, 2024

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.

Locations

FR(1)