Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study

Completed

• Conditions: Sepsis

• Registration Number: NCT06242561
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

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.

Detailed Description

Vascular refill is central to the initial management of hypotension in sepsis, and is often started even before the patient is admitted to intensive care. Over the past 20 years, we have moved from ultraliberal fluid resuscitation to restrictive resuscitation. Indeed, in the early 2000s, the implementation of an early and aggressive hemodynamic optimization strategy, including liberal vascular filling, improved the survival of critically ill patients, and ushered in the era of the Surviving Sepsis Campaign. However, studies have shown increased morbidity and mortality associated with a positive fluid balance. Restrictive approaches to fluid resuscitation and/or deressuscitation were then tested. While these approaches failed to demonstrate any benefit in terms of mortality, they did have the merit of demonstrating their feasibility and good tolerability, albeit with a little-explored pathophysiology. Little is known about the problem of dilutional anemia in the acute phase of septic shock.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total volume of fluids administered during the first 48 hours of ICU stay	48 hours from ICU admission	Total volume of fluids (ml)

Secondary Outcome Measures

Name	Time	Method
In hospital mortality	at hospital discharge : an average of 15 days	rate
Haemoglobinemia	48 hours from ICU admission	Haemoglobinemia (g/dl)
Volume of fluids administered before admission in ICU (ml)	at ICU admission	Volume of fluids (ml)
Length of hospital stay	at hospital discharge : an average of 15 days	Length of hospital stay (days)
Type of fluids administered during the first 48 hours of ICU stay	48 hours from ICU admission	resuscitation, nutrition, maintenance // crystalloids, colloids, dextrose, sodium bicarbonate

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital Mercy; 🇫🇷 Metz, France