Septic ShockOPTIFLUIDNCT04947904
OPTImized Restrictive Strategy Targeting Non-Resuscitative FLUIDs in Septic Shock: Pilot Study.
A study testing Reduction of the patient's fluid intake during the first 7 days in people with Septic Shock and Electrolyte and Fluid Balance Conditions, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock, Electrolyte and Fluid Balance Conditions
- What is being tested?
- Reduction of the patient's fluid intake during the first 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Sep 2021to 25 Feb 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from an infection already documented or suspected
- Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points
- Patient with refractory hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg in spite of resuscitation with an adequate volume of intravenous fluids (according to the recommendations of the Surviving Sepsis campaign). The treatment by vasopressor must have been started less than 24 hours before inclusion and randomization.
- Patient with hyperlactatemia (blood lactate > 2 mmol / L). This criterion must be fulfilled at least once for the purpose of the diagnosis within the 24 hours preceding inclusion and randomization.
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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 in an exclusion period determined by another study.
- Patient under legal protection.
- Pregnant patient (positive serum pregnancy test).
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier d'Alès
Alès, 30100
CHU de DIJON
Dijon, 21000
CHU de Montpellier
Montpellier, 34000
Nimes University Hospital
Nîmes, 30000
About this study
Official title: Impact on Fluid Balance of an Optimised Restrictive Strategy Targeting Non-Resuscitative Fluids in Intensive Care Patients Hospitalised for Septic Shock: an Open-label, Multi-Centre, Randomised, Controlled Pilot Study.
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.
Read the detailed description
Sepsis and its most severe form, septic shock, are the cause of nearly 30% of admission in intensive care unit (ICU). The related mortality rate varies from 20 to 60% according to the studied population and the type of the study. With the concomitant and rapid treatment of the source of infection, hemodynamic optimization with fluid infusion (fluid resuscitation) is the cornerstone of management of patients in septic shock. Nevertheless, fluid overload has been shown to be associated with poor outcome. The negative effects of a positive fluid balance on ICU outcomes for septic patients has been well established.
In patients with acute respiratory distress syndrome, a restrictive fluid therapy has been associated with shorter use of mechanical ventilation. In patients with acute renal failure, fluid overload is associated with longer need of renal replacement therapy. In patients with septic shock numerous non-randomised studies reported that a positive fluid balance at Day 3, Day 5 was associated with an increased risk of mortality.
Actually, in patients with septic shock the part of resuscitation fluid is only the third of the total fluid input that can attain 25 liters at day 3. Some studies reported more specifically the role of the different types of fluid in the fluid balance at D3 and D5. In a retrospective single centre study including 14654 ICU patients over 10 years, the authors distinguished resuscitation, replacement and maintenance fluids, blood products, nutrition and fluid creep (to concentrate electrolytes, keep venous access and to infuse continuous medications). They reported that maintenance fluids and fluid creep represent more than 50% of fluid input during the first 5 ICU days with significant sodium and chloride loads. In a retrospective multi-centre study involving 400 patients mechanically ventilated > 24 h in 10 ICUs, the authors reported that maintenance and fluid creep represented more than 50% of the fluids infused during the first 3 ICU days. In this study, fluid balance at Day3 was an independent risk factor for 30-day mortality.
All these findings could lead to hypothesize that a restrictive strategy in fluid input for the maintenance of fluid and creep fluid could be associated with a better outcome without impairing the resuscitation phase.
To our knowledge, to date, no study has focused on a restrictive strategy targeting non-resuscitative fluid input to optimize fluid balance in patients with septic shock. OPTIFLUID will be the first randomised controlled trial with the objective of reducing fluid balance through a fluid restriction targeted at all fluids other than resuscitative fluids.
The only existing interventional studies on targeted restriction were limited to resuscitative intravenous fluids, and they failed showing a benefit.
By optimizing fluid therapy, our approach is likely to improve patient-centred outcomes, but in this pilot study we focus only on the fluid balance and the safety.
- Being tested
- Reduction of the patient's fluid intake during the first 7 days
- Keywords
- Shock, Septic., Fluid Balance
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of the patient's fluid intake during the first 7 daysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Secondary outcomes (33)
Change from baseline in fluid balance at day 7
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 7 and is measured in millilitres per kgs of patient's weight at baseline.
Measured: Day 1 to 7
Change from baseline in patient's weight at day 5
The patient's weight will be recorded every day in kgs. The difference in the patient's weight between Day 1 and Day 5 will be recorded in kgs.
Measured: Day 1 to 5
Change from baseline in patient's weight at day 7
The patient's weight will be recorded every day in kgs. The difference in the patient's weight between Day 1 and Day 7 will be recorded in kgs.
Measured: Day 1 to 7
Change from baseline in central venous pressure at day 5
Central venous pressure will be recorded every day in mmHg
Measured: Day 1 to 5
Change from baseline in central venous pressure at day 7
Central venous pressure will be recorded every day in mmHg
Measured: Day 1 to 7
Vital status at Day 7
The number of patients still alive on Day 7 will be recorded
Measured: Day 7
Vital status at Day 28
The number of patients still alive on Day 28 will be recorded
Measured: Day 28
Proportion of patients alive without organ failure at Day 7
The Sequential Organ Failure Assessment (SOFA) score will be used will be used to record the patient's condition. The score ranges from 0 to 3 points : one point for each of Low blood pressure (SBP ≤ 100 mmHg), High respiratory rate (≥ 22 breaths/min) and Altered mentation (GCS ≤ 14).The presence of 2 or more SOFA points near the onset of infection was associated with a greater risk of death or prolonged intensive care unit stay. These are outcomes that are more common in infected patients who may be septic than those with uncomplicated infection. The number of patients with a SOFA score = 0 will be recorded.
Measured: Day 7
Proportion of patients alive without organ failure at Day 28
The Sequential Organ Failure Assessment (SOFA) score will be used to record the patient's condition. The score ranges from 0 to 3 points : one point for each of Low blood pressure (SBP ≤ 100 mmHg), High respiratory rate (≥ 22 breaths/min) and Altered mentation (GCS ≤ 14).The presence of 2 or more SOFA points near the onset of infection was associated with a greater risk of death or prolonged intensive care unit stay. These are outcomes that are more common in infected patients who may be septic than those with uncomplicated infection. The number of patients with a SOFA score = 0 will be recorded.
Measured: Day 28
Vasopressors free days
The number of days the patient has survived without the use of vasopressors will be recorded.
Measured: Day 28
Invasive mechanical ventilation free days
The number of days the patient has survived without the use of invasive mechanical ventilation will be recorded.
Measured: Day 28
Renal-Replacement Therapy free days
The number of days the patient has survived without the use of renal-replacement therapy will be recorded.
Measured: Day 28
Intensive Care Unit Length of stay
The total number of days spent in the ICU will be recorded.
Measured: Day 28
Intensive Care Unit Free Days
The number of days spent in hospital outside the intensive care unit will be recorded.
Measured: Day 28
Hospital Length of stay
The total number of days spent in hospital will be recorded.
Measured: Day 28
Frequency of metabolic disorders - moderate hypernatremia
The frequency of moderate hypernatremia will be recorded to evaluate the safety and tolerance of adverse events associated with the optimal restrictive strategy. Moderate hypernatremia = natremia between 146 and 150 mmol/l.
Measured: Day 7
Frequency of metabolic disorders - severe hypernatremia
The frequency of severe hypernatremia will be recorded to evaluate the safety and tolerance of adverse events associated with the optimal restrictive strategy. Severe hypernatremia = natremia over 150 mmol/l.
Measured: Day 7
Frequency of metabolic disorders - hyponatremia
The frequency of hyponatremia will be recorded to evaluate the safety and tolerance of adverse events associated with the optimal restrictive strategy. Hyponatremia = natremia below 130 mmol/l
Measured: Day 7
Frequency of metabolic disorders - hyperkalemia
The frequency of hyperkalemia will be recorded to evaluate the safety and tolerance of adverse events associated with the optimal restrictive strategy (hyperkalemia over 6 mmol/l
Measured: Day 7
Frequency of metabolic disorders - hypoglycemia
The frequency of hypoglycemia < 0.6g/l will be recorded to evaluate the safety and tolerance of adverse events associated with the optimal restrictive strategy.
Measured: Day 7
Insulin cumulative dose at Day 7
The cumulative dose of insulin administered over 7 days will be recorded.
Measured: Day 7
Frequency of moderate acute kidney injury
The frequency of moderate acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) score 2 will be recorded.
Measured: Day 7
Frequency of severe acute kidney injury
The frequency of severe acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) score 3 will be recorded.
Measured: Day 7
Cumulative dose of diuretics at day 7
The cumulative dose of diuretics administered over 7 days will be recorded.
Measured: Day 7
Frequency of Stage 3 pressure sores
The frequency of Stage 3 pressure sores acquired in the resuscitation unit will be recorded.
Measured: Day 7
Daily fluid intake: Resuscitation Fluids
The daily volume of crystalloids and colloids supplied to the patient will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake: Blood Transfusions and Blood Derivatives
The daily volume of blood transfusions, Blood Derivatives and plasma-derived products supplied to the patient will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake: Maintenance Fluids
The amount of Maintenance fluids (prescribed to provide water and electrolytes when patients are unable to ingest food or fluids) will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake: Fluid Creep
The volume of fluids administered unintentionally as a vehicle for intravenous, oral, or enteral medication will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake : Enteral Nutrition
The amount of fluid in terms of enteral nutrition will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake : Parenteral Nutrition
The amount of fluid in terms of parenteral nutrition will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake : Water
The volume of water in terms of oral intake and the volume administered in the nasogastric tube will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Daily fluids intake : intravenous fluids to treat hypernatremia
The amount of fluids given intravenously to treat hypernatremia (intravenous hydration with a 2.5% glucose solution) will be recorded daily in milliliters per kilograms of patient's weight
Measured: Day 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start20 Sep 2021
- Primary completion27 Jan 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947904
- Sponsor's protocol ID
- NIMAO/2019/SB-01
- Other IDs
- 2020-A01952-37
- Acronym
- OPTIFLUID
- Status last verified
- Dec 2025
- First submitted
- 14 Jun 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39709493
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Fluid Balance of an Optimised Restrictive Strategy Targeting Non-Resuscitative Fluids in Intensive Care Patients Hospitalised for Septic Shock: an Open-label, Multi-Centre, Randomised, Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT04947904
- Acronym / sponsor ID
- OPTIFLUID / NIMAO/2019/SB-01
- Keywords
- Shock, Septic., Fluid Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier, Centre Hospitalier Universitaire Dijon
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 1 Jul 2021 (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.
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.
Detailed description
Sepsis and its most severe form, septic shock, are the cause of nearly 30% of admission in intensive care unit (ICU). The related mortality rate varies from 20 to 60% according to the studied population and the type of the study. With the concomitant and rapid treatment of the source of infection, hemodynamic optimization with fluid infusion (fluid resuscitation) is the cornerstone of management of patients in septic shock. Nevertheless, fluid overload has been shown to be associated with poor outcome. The negative effects of a positive fluid balance on ICU outcomes for septic patients has been well established.
In patients with acute respiratory distress syndrome, a restrictive fluid therapy has been associated with shorter use of mechanical ventilation. In patients with acute renal failure, fluid overload is associated with longer need of renal replacement therapy. In patients with septic shock numerous non-randomised studies reported that a positive fluid balance at Day 3, Day 5 was associated with an increased risk of mortality.
Actually, in patients with septic shock the part of resuscitation fluid is only the third of the total fluid input that can attain 25 liters at day 3. Some studies reported more specifically the role of the different types of fluid in the fluid balance at D3 and D5. In a retrospective single centre study including 14654 ICU patients over 10 years, the authors distinguished resuscitation, replacement and maintenance fluids, blood products, nutrition and fluid creep (to concentrate electrolytes, keep venous access and to infuse continuous medications). They reported that maintenance fluids and fluid creep represent more than 50% of fluid input during the first 5 ICU days with significant sodium and chloride loads. In a retrospective multi-centre study involving 400 patients mechanically ventilated > 24 h in 10 ICUs, the authors reported that maintenance and fluid creep represented more than 50% of the fluids infused during the first 3 ICU days. In this study, fluid balance at Day3 was an independent risk factor for 30-day mortality.
All these findings could lead to hypothesize that a restrictive strategy in fluid input for the maintenance of fluid and creep fluid could be associated with a better outcome without impairing the resuscitation phase.
To our knowledge, to date, no study has focused on a restrictive strategy targeting non-resuscitative fluid input to optimize fluid balance in patients with septic shock. OPTIFLUID will be the first randomised controlled trial with the objective of reducing fluid balance through a fluid restriction targeted at all fluids other than resuscitative fluids.
The only existing interventional studies on targeted restriction were limited to resuscitative intravenous fluids, and they failed showing a benefit.
By optimizing fluid therapy, our approach is likely to improve patient-centred outcomes, but in this pilot study we focus only on the fluid balance and the safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised Restrictive Strategy | Experimental | Other: Reduction of the patient's fluid intake during the first 7 daysThe 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. |
| Control | No intervention | –Resuscitation fluids, maintenance fluids, nutrition and drugs will be administered as usually performed and following most recent guidelines. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient suffering from an infection already documented or suspected
- Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points
- Patient with refractory hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg in spite of resuscitation with an adequate volume of intravenous fluids (according to the recommendations of the Surviving Sepsis campaign). The treatment by vasopressor must have been started less than 24 hours before inclusion and randomization.
- Patient with hyperlactatemia (blood lactate > 2 mmol / L). This criterion must be fulfilled at least once for the purpose of the diagnosis within the 24 hours preceding inclusion and randomization.
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Reduction of the patient's fluid intake during the first 7 daysThe 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. | Other | Optimised Restrictive Strategy |
Primary outcome
Fluid balance at day 5
Time frame: 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.
33 secondary outcomes
Change from baseline in fluid balance at day 7
Time frame: Day 1 to 7
Change from baseline in patient's weight at day 5
Time frame: Day 1 to 5
Change from baseline in patient's weight at day 7
Time frame: Day 1 to 7
Change from baseline in central venous pressure at day 5
Time frame: Day 1 to 5
Change from baseline in central venous pressure at day 7
Time frame: Day 1 to 7
Vital status at Day 7
Time frame: Day 7
Vital status at Day 28
Time frame: Day 28
Proportion of patients alive without organ failure at Day 7
Time frame: Day 7
Proportion of patients alive without organ failure at Day 28
Time frame: Day 28
Vasopressors free days
Time frame: Day 28
Invasive mechanical ventilation free days
Time frame: Day 28
Renal-Replacement Therapy free days
Time frame: Day 28
Intensive Care Unit Length of stay
Time frame: Day 28
Intensive Care Unit Free Days
Time frame: Day 28
Hospital Length of stay
Time frame: Day 28
Frequency of metabolic disorders - moderate hypernatremia
Time frame: Day 7
Frequency of metabolic disorders - severe hypernatremia
Time frame: Day 7
Frequency of metabolic disorders - hyponatremia
Time frame: Day 7
Frequency of metabolic disorders - hyperkalemia
Time frame: Day 7
Frequency of metabolic disorders - hypoglycemia
Time frame: Day 7
Insulin cumulative dose at Day 7
Time frame: Day 7
Frequency of moderate acute kidney injury
Time frame: Day 7
Frequency of severe acute kidney injury
Time frame: Day 7
Cumulative dose of diuretics at day 7
Time frame: Day 7
Frequency of Stage 3 pressure sores
Time frame: Day 7
Daily fluid intake: Resuscitation Fluids
Time frame: Day 1 to 7
Daily fluids intake: Blood Transfusions and Blood Derivatives
Time frame: Day 1 to 7
Daily fluids intake: Maintenance Fluids
Time frame: Day 1 to 7
Daily fluids intake: Fluid Creep
Time frame: Day 1 to 7
Daily fluids intake : Enteral Nutrition
Time frame: Day 1 to 7
Daily fluids intake : Parenteral Nutrition
Time frame: Day 1 to 7
Daily fluids intake : Water
Time frame: Day 1 to 7
Daily fluids intake : intravenous fluids to treat hypernatremia
Time frame: Day 1 to 7
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 10 Dec 2025.
- Results publication: PubMed 39709493Boulet 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of the patient's fluid intake during the first 7 days in people with Septic Shock and Electrolyte and Fluid Balance Conditions, run by Centre Hospitalier Universitaire de Nīmes at 4 sites 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 7 inclusion and 11 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Fluid balance at day 5 (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947904, which also lists 1 linked publication.
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 10 Dec 2025.