NCT04947904: OPTIFLUID

OPTImized Restrictive Strategy Targeting Non-Resuscitative FLUIDs in Septic Shock: Pilot Study.

Completed NA Last updated 10 December 2025

What this trial tests

NA trial testing Reduction of the patient's fluid intake during the first 7 days in Septic Shock in 50 participants. Completed in 25 February 2023.

Timeline

20 September 2021

Primary endpoint
27 January 2023

25 February 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	50
Start date	20 September 2021
Primary completion	27 January 2023
Estimated completion	25 February 2023
Sites	4 locations across France

Drugs / interventions tested

• Reduction of the patient's fluid intake during the first 7 days

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Electrolyte and Fluid Balance Conditions — all drugs for Electrolyte and Fluid Balance Conditions →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

Adults 18 to 85, any sex, with Septic Shock or Electrolyte and Fluid Balance Conditions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intravenous fluids are one of the keystones in the initial management of patients with septic shock, but they inevitably lead to a fluid overload, which is associated with poor outcome.

So far no studies have evaluated the interest of a restrictive strategy for managing fluid intake targeting all non-resuscitative fluids (fluids for maintenance and drug dilution as well as nutrition) and especially the impact of this restrictive strategy on fluid overload.

The hypothesis of this research is that an optimised restrictive strategy targeting all non-resuscitative fluids in patients hospitalised in the intensive care unit for septic shock, will have an impact on fluid balance in these patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluid accumulation and major adverse kidney events in sepsis: a multicenter observational study.
   Mele A, Cerminara E, Häbel H, Rodriguez-Galvez B, et al · · 2022 · cited 18× · PMID 35781636 · DOI 10.1186/s13613-022-01040-6
2. Impact on fluid balance of an optimized restrictive strategy targeting non-resuscitative fluids in intensive care patients with septic shock: a single-blind, multicenter, randomized, controlled, pilot study.
   Boulet N, Quenot JP, Serrand C, Antier N, et al · · 2024 · cited 1× · PMID 39709493 · DOI 10.1186/s13054-024-05155-z