SepsisQUADSNCT06242561
Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study
An observational study of Sepsis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Data collection from sepsis management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic patients
Who may be able to join
- 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.
Who cannot join
- patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study: a 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Data collection from sepsis management
- Keywords
- hemoglobin levels
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from sepsis managementBehavioural
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of fluids administered during the first 48 hours of ICU stay
Total volume of fluids (ml)
Measured: 48 hours from ICU admission
Secondary outcomes (5)
Haemoglobinemia
Haemoglobinemia (g/dl)
Measured: 48 hours from ICU admission
Type of fluids administered during the first 48 hours of ICU stay
resuscitation, nutrition, maintenance // crystalloids, colloids, dextrose, sodium bicarbonate
Measured: 48 hours from ICU admission
Volume of fluids administered before admission in ICU (ml)
Volume of fluids (ml)
Measured: at ICU admission
In hospital mortality
rate
Measured: at hospital discharge : an average of 15 days
Length of hospital stay
Length of hospital stay (days)
Measured: at hospital discharge : an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien BARRAUD, MD, Principal investigator, CHR Metz Thionville Hopital Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242561
- Sponsor's protocol ID
- 2023-14Obs-CHRMT
- Acronym
- QUADS
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study: a Preliminary Retrospective Study
- ClinicalTrials.gov ID
- NCT06242561
- Acronym / sponsor ID
- QUADS / 2023-14Obs-CHRMT
- Conditions
- Sepsis
- Keywords
- hemoglobin levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection from sepsis managementobservational study | Behavioural | – |
Primary outcome
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)
5 secondary outcomes
Haemoglobinemia
Time frame: 48 hours from ICU admission
Type of fluids administered during the first 48 hours of ICU stay
Time frame: 48 hours from ICU admission
Volume of fluids administered before admission in ICU (ml)
Time frame: at ICU admission
In hospital mortality
Time frame: at hospital discharge : an average of 15 days
Length of hospital stay
Time frame: at hospital discharge : an average of 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien BARRAUD, MD principal investigator
CHR Metz Thionville Hopital Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of fluids administered during the first 48 hours of ICU stay (time frame: 48 hours from ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.