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

Sepsis Clinical Trial

— QUADS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242561
• Other study ID #: 2023-14Obs-CHRMT
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: arpine.el-nar[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Behavioral:
• Data collection from sepsis management
observational study

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

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