Clinical trial NCT06242561: Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study
Official title: Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study: a Preliminary Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: hemoglobin levels
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total volume of fluids administered during the first 48 hours of ICU stay
timeFrame: 48 hours from ICU admission
Secondary outcomes:
measure: Haemoglobinemia
timeFrame: 48 hours from ICU admission
measure: Type of fluids administered during the first 48 hours of ICU stay
timeFrame: 48 hours from ICU admission
measure: Volume of fluids administered before admission in ICU (ml)
timeFrame: at ICU admission
measure: In hospital mortality
timeFrame: at hospital discharge : an average of 15 days
measure: Length of hospital stay
timeFrame: at hospital discharge : an average of 15 days
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital Mercy
name: Damien BARRAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: