Effects of Fluid Balance Control in Critically Ill Patients

NCT02765009 | Completed DMC

• 1 other identifier: 2015-A00662-47
• Study Type: interventional
• Target: 1,411
• Locations: 1 country
• Sites: 11

Brief Summary

Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

Conditions

Fluid Shifts; Critical Care

Keywords

Fluid overload; Multiple organ failure; Diuretics; Fluid restriction; Body weight

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 60 days after inclusion

  Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected

  60 days

Secondary Outcomes (12)

• Fluid balance control at day 7

  7 days

• Fluid balance control at day 14

  14 days

• All-cause mortality at 28-day after inclusion

  28 days

• All-cause in-hospital mortality

  Up to 24 weeks

• All-cause mortality at 365 days after inclusion

  365 days

Study Arms (2)

Control

NO INTERVENTION

Usual care provided according to the ward policy. Patients have to be weighed at least on admission (day 0), day 7 and day 14.

Strategy

EXPERIMENTAL

Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)

Drug: diuretics; Drug: albumin; Other: fluid restriction; Device: renal replacement

Interventions

diuretics DRUG

Used to reduce fluid overload as evidenced by weight gain

Also known as: hydrochlorothiazide, bumetanide, furosemide

Strategy

albumin DRUG

Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients

Strategy

fluid restriction OTHER

Used to reduce fluid overload

Strategy

renal replacement DEVICE

Used to reduce fluid overload in patients with renal replacement

Also known as: ultrafiltration

Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients under mechanical ventilation, admitted for \> 48h and \<72h and no discharge planned for the next 24h

You may not qualify if:

• Age \< 18 years
• Failure to weigh the patient
• Multiple trauma
• Transfer from another ICU with a previous stay \> 24h
• High probability of withdrawing treatment for ethical purposes within 7 days
• Pregnancy
• Patient refusal

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Ministry of Health, France: collaborator

Study Sites (11)

Hopital Nord Franche-Comté

Belfort, 90000, France

Location

Centre Hospitalier Universitaire

Dijon, 21000, France

Location

Centre Hospitalier Universitaire

Lyon, 69000, France

Location

Centre Hospitalier Régional

Metz, 57000, France

Location

Centre Hospitalier Régional et Universitaire

Nancy, 54000, France

Location

Groupe Hospitalier Saint Joseph

Paris, 75000, France

Location

Centre Hospitalier intercommunal

Poissy, 78303, France

Location

Centre Hospitalier Régional et Universitaire

Strasbourg, 67000, France

Location

CentreHospitalier Régional et universitaire

Strasbourg, 67000, France

Location

Centre Hospitalier Régional

Thionville, 57000, France

Location

Centre Hospitalier

Verdun, 55100, France

Location

Related Publications (4)

• Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.

  PMID: 31260794 BACKGROUND

• Buzzi M, Ricci L, Gibot S, Argaud L, Badie J, Bruel C, Charpentier C, Outin H, Louis G, Monnier A, Quenot JP, Schneider F, Minary L, Agrinier N. Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation. BMC Med Res Methodol. 2024 Jul 24;24(1):160. doi: 10.1186/s12874-024-02288-1.

  PMID: 39048932 DERIVED

• Mansouri A, Buzzi M, Gibot S, Charpentier C, Schneider F, Louis G, Outin H, Monnier A, Quenot JP, Badie J, Argaud L, Bruel C, Soudant M, Agrinier N; the POINCARE-2 group. Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial. Crit Care. 2023 Nov 6;27(1):426. doi: 10.1186/s13054-023-04701-5.

  PMID: 37932787 DERIVED

• Bollaert PE, Monnier A, Schneider F, Argaud L, Badie J, Charpentier C, Meziani F, Bemer M, Quenot JP, Buzzi M, Outin H, Bruel C, Ziegler L, Gibot S, Virion JM, Alleyrat C, Louis G, Agrinier N. Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial. Crit Care. 2023 Feb 21;27(1):66. doi: 10.1186/s13054-023-04357-1.

  PMID: 36810101 DERIVED

MeSH Terms

Conditions

Edema; Multiple Organ Failure; Body Weight

Interventions

Diuretics; Hydrochlorothiazide; Bumetanide; Furosemide; Albumins; Ultrafiltration

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shock; Pathologic Processes

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amides; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfanilamides; Aniline Compounds; Amines; Proteins; Amino Acids, Peptides, and Proteins; Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• El Mehdi Siaghy

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: May 25, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)