Effects of Fluid Balance Control in Critically Ill Patients

NCT ID: NCT02765009

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2020-05-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Strategy

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)

Group Type: EXPERIMENTAL

diuretics

Intervention Type: DRUG

Used to reduce fluid overload as evidenced by weight gain

albumin

Intervention Type: DRUG

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

fluid restriction

Intervention Type: OTHER

Used to reduce fluid overload

renal replacement

Intervention Type: DEVICE

Used to reduce fluid overload in patients with renal replacement

Interventions

diuretics

Used to reduce fluid overload as evidenced by weight gain

Intervention Type: DRUG

albumin

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

Intervention Type: DRUG

fluid restriction

Used to reduce fluid overload

Intervention Type: OTHER

renal replacement

Used to reduce fluid overload in patients with renal replacement

Intervention Type: DEVICE

Other Intervention Names

hydrochlorothiazide; bumetanide; furosemide; ultrafiltration

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

El Mehdi Siaghy

Role: STUDY_DIRECTOR

Central Hospital, Nancy, France

Locations

Hopital Nord Franche-Comté

Belfort, , France

Centre Hospitalier Universitaire

Dijon, , France

Centre Hospitalier Universitaire

Lyon, , France

Centre Hospitalier Régional

Metz, , France

Centre Hospitalier Régional et Universitaire

Nancy, , France

Groupe Hospitalier Saint Joseph

Paris, , France

Centre Hospitalier intercommunal

Poissy, , France

Centre Hospitalier Régional et Universitaire

Strasbourg, , France

CentreHospitalier Régional et universitaire

Strasbourg, , France

Centre Hospitalier Régional

Thionville, , France

Centre Hospitalier

Verdun, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 31260794 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39048932 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37932787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36810101 (View on PubMed)

Other Identifiers

2015-A00662-47

Identifier Type: -

Identifier Source: org_study_id