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Completed

NCT Number: NCT05249088

Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 18 years of age)
  • Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
  • Inclusion within 12 hours after ICU admission.

Exclusion criteria

  • Confirmed or suspected pregnancy

Treatment and study plan

Protocolised reduction of non-resuscitation fluids

Other
  • Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated
  • Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances
  • Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice
  • Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this
  • Parenteral nutrition is administered according to local protocol
  • Intravenous medications are concentrated according to a predefined protocol
  • Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h)

Usual Care

Other

Participants receive non-resuscitation fluids according to local routines, with the following stipulations:

  • Maintenance fluids (crystalloids and/or glucose and/or enteral water) are given at a dose of 1 ml/kg/h unless local protocol states otherwise
  • Glucose is used at maximal concentration of 10% unless local protocol states otherwise.
  • Medications are concentrated according to local protocol

Primary outcomes

  1. Difference in fluid administration

    Time frame: Within the first three days after inclusion (days 0-3)

    Total difference in litres of administered fluids between groups

Secondary outcomes

  1. Proportion of participants with sufficient clinical outcome data

    Time frame: Within 90 days after inclusion

    Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia)

  2. Proportion of participants assessed by EQ5D-5L and MoCA

    Time frame: 6 months after inclusion

    Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA)

  3. Inclusion of eligible patients

    Time frame: During inclusion

    Fraction of all eligible patients who were randomised and consented

  4. Protocol violations

    Time frame: Within 90 days after inclusion

    Fraction of patients experiencing at least one protocol violation

Other outcomes

  1. Mortality

    Time frame: 90 days after inclusion

    All-cause mortality

  2. Complications in the ICU

    Time frame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days

    Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury

  3. Days alive and free of mechanical ventilation

    Time frame: Within 90 days after inclusion

    Days alive and free of mechanical ventilation

  4. Cognitive function

    Time frame: 6 months after inclusion

    Cognitive function measured using MoCA

  5. Health-Related Quality of Life

    Time frame: 6 months after inclusion

    Health-Related Quality of Life measured using the EQ5D-5L questionnaire

  6. Total volume of non-resuscitation fluids administered

    Time frame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion

    Total volume of non-resuscitation fluids administered

  7. Renal function

    Time frame: Within 90 days after inclusion

    Acute kidney injury stages according to Kidney Disease Improving Global Outcomes [KDIGO] criteria, urea, and days alive and free of renal replacement therapy [RRT]

  8. Gastrointestinal function

    Time frame: Within 90 days after inclusion

    Days alive with full enteral nutrition

  9. Total volume of resuscitation fluids administered

    Time frame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion

    Total volume of resuscitation fluids administered

  10. Cumulative fluid balance

    Time frame: On day 3 and day 5 after inclusion

    Cumulative fluid balance (excluding evaporation)

  11. Diuretics administered

    Time frame: Within the first five days (days 0-5) after inclusion

    Daily dose and type of diuretics administered

  12. Hemodynamic stability

    Time frame: Within the first five days (days 0-5) after inclusion

    Daily highest dose of noradrenaline, daily lactate, and cardiovascular sequential organ failure assessment [SOFA] score

  13. Ischemic events

    Time frame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days

    Number of patients with one or more ischemic events while in the ICU (cerebral, cardiac, intestinal or limb ischemia)

  14. GOSE score

    Time frame: 6 months after inclusion

    Glasgow Outcome Scale Extended (GOSE) score

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 21, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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