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Completed

NCT Number: NCT06242561

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection from sepsis management

Behavioral

observational study

Primary outcomes

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

    Time frame: 48 hours from ICU admission

    Total volume of fluids (ml)

Secondary outcomes

  1. Haemoglobinemia

    Time frame: 48 hours from ICU admission

    Haemoglobinemia (g/dl)

  2. Type of fluids administered during the first 48 hours of ICU stay

    Time frame: 48 hours from ICU admission

    resuscitation, nutrition, maintenance // crystalloids, colloids, dextrose, sodium bicarbonate

  3. Volume of fluids administered before admission in ICU (ml)

    Time frame: at ICU admission

    Volume of fluids (ml)

  4. In hospital mortality

    Time frame: at hospital discharge : an average of 15 days

    rate

  5. Length of hospital stay

    Time frame: at hospital discharge : an average of 15 days

    Length of hospital stay (days)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: QUADS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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