An interventional study of Reduction of the patient's fluid intake during the first 7 days in Septic Shock and Electrolyte and Fluid Balance Conditions, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 4 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Prevention
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.
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.
864 studies on the registry are indexed under Shock, Septic; 209 are open to participants now.
This study's enrollment of 50 is below the median of 79 across 531 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
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
Resuscitation fluids, maintenance fluids, nutrition and drugs will be administered as usually performed and following most recent guidelines.
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.
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.
Time frame: Day 5
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to 7
Change from baseline in central venous pressure at day 5
Central venous pressure will be recorded every day in mmHg
Time frame: Day 1 to 5
Change from baseline in central venous pressure at day 7
Central venous pressure will be recorded every day in mmHg
Time frame: Day 1 to 7
Vital status at Day 7
The number of patients still alive on Day 7 will be recorded
Time frame: Day 7
Vital status at Day 28
The number of patients still alive on Day 28 will be recorded
Time frame: 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.
Time frame: 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.
Time frame: Day 28
Vasopressors free days
The number of days the patient has survived without the use of vasopressors will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: Day 28
Intensive Care Unit Length of stay
The total number of days spent in the ICU will be recorded.
Time frame: Day 28
Intensive Care Unit Free Days
The number of days spent in hospital outside the intensive care unit will be recorded.
Time frame: Day 28
Hospital Length of stay
The total number of days spent in hospital will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 7
Insulin cumulative dose at Day 7
The cumulative dose of insulin administered over 7 days will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: Day 7
Cumulative dose of diuretics at day 7
The cumulative dose of diuretics administered over 7 days will be recorded.
Time frame: Day 7
Frequency of Stage 3 pressure sores
The frequency of Stage 3 pressure sores acquired in the resuscitation unit will be recorded.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to 7
Plan to share: Undecided
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Centre Hospitalier Universitaire de Nīmes