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

NCT04947904 | Completed

• 2 other identifiers: NIMAO/2019/SB-012020-A01952-37
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Septic Shock; Electrolyte and Fluid Balance Conditions

Keywords

Shock, Septic.; Fluid Balance

Outcome Measures

Primary Outcomes (1)

• Fluid balance at day 5

  Fluid intakes are noted on a daily basis (parenteral, enteral, and oral routes) and all outgoing fluids (diuresis, depletion on renal-replacement therapy, drainage, diarrhoea (if the volume is measurable). The difference between these daily fluid intakes and outgoing fluids is the daily fluid balance. Fluid balance on Day 5 is the sum total of the fluid balances from Days 1 to 5 and is measured in millilitres per kgs of patient's weight at baseline.

  Day 5

Secondary Outcomes (33)

• Change from baseline in fluid balance at day 7

  Day 1 to 7

• Change from baseline in patient's weight at day 5

  Day 1 to 5

• Change from baseline in patient's weight at day 7

  Day 1 to 7

• Change from baseline in central venous pressure at day 5

  Day 1 to 5

• Change from baseline in central venous pressure at day 7

  Day 1 to 7

Study Arms (2)

Optimised Restrictive Strategy

EXPERIMENTAL

The volume of non-resuscitative fluids infused to the patient will be reduced by the doctor in charge of the patient for the first 7 days of the patient's stay in ICU according to a special protocol.

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

Control

NO INTERVENTION

Resuscitation fluids, maintenance fluids, nutrition and drugs will be administered as usually performed and following most recent guidelines.

Interventions

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

The volume of fluids infused to the patient will be reduced by the doctor in charge of the patient for the first 7 days of the patient's stay in the intensive care unit according to a protocol with instructions to reduce fluid intake as far as possible in terms of maintenance fluids, dilution of medication and artificial nutrition. This protocol will be begun immediately following the patient's inclusion on Day 1 and pursued for 7 days after inclusion (i.e. from Day 1 - to Day 7). The fluid restriction strategy does not involve the administration of any medication (i.e. diuretics). A clinical pharmacist will help the intensive care teams apply the fluid restriction protocol with a daily check. If the restrictive strategy leads to hypovolemia and / or a electrolyte anomaly (sodium, potassium, chloride, etc.), the physician in charge will be authorised to treat these anomalies in conformance with the protocol recommendations.

Optimised Restrictive Strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from an infection already documented or suspected
• Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points
• Patient or close relative / legal representative / family member / curator / tutor must have given written informed consent and signed the consent form for the patient included in an emergency situation
• Patient must be covered by a health insurance scheme.
• Adult patient (≥18 years) under 85 years old (\< 85).

You may not qualify if:

• Patient who has had a previous episode of septic shock requiring vasopressor administration or mechanical ventilation or renal replacement therapy during the current ICU stay.
• A patient whose life expectancy is shortened due to his/her initial health condition or a moribund patient whose life expectancy is less than 48 hours or whose decision to limit comprehensive care was made before including the patient.
• Patient who has had a recent cardiac arrest (during current hospital stay)
• Patient requiring emergency renal-replacement therapy (hyperkalemia \[potassium \> 6.5 mmol/l\] refractory to medical treatment and/or metabolic acidosis \[pH \<7.15 and partial pressure of carbon dioxide (pCO2) \<45 mmHg\] refractory to medical treatment and/or pulmonary edema in anuric patients who do not respond to diuretic therapy).
• Patient with KDIGO 3 acute kidney injury and likely to require renal-replacement therapy within the next 24 hours, as determined by the patient's clinician in charge
• Patients with end-stage chronic renal failure or patients already undergoing chronic dialysis
• Severely malnourished patient in whom nutritional support is an emergency procedure (body mass index \<18 kg / m2)
• Patient participating in or having participated in an interventional study with similar patient outcome in the previous 3 months.
• Patient under legal protection.
• Pregnant patient (positive serum pregnancy test).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• University Hospital, Montpellier: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (4)

Centre Hospitalier d'Alès

Alès, 30100, France

Location

CHU de DIJON

Dijon, 21000, France

Location

CHU de Montpellier

Montpellier, 34000, France

Location

Nimes University Hospital

Nîmes, 30000, France

Location

Related Publications (1)

• Boulet N, Quenot JP, Serrand C, Antier N, Garnier S, Buzancais A, Muller L, Roger C, Lefrant JY, Barbar SD. 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. Crit Care. 2024 Dec 21;28(1):429. doi: 10.1186/s13054-024-05155-z.

  PMID: 39709493 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 1, 2021
• Study Start: September 20, 2021
• Primary Completion: January 27, 2023
• Study Completion: February 25, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (4)