Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients

NCT04576806 | Withdrawn

• 1 other identifier: EPN 2019-05492
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Hemodynamic measurements will be made for 2 hours following the bolus, and laboratory values will be noted. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.

Conditions

Critical Illness; Sepsis; Fluid Overload; Hemodynamic Instability

Keywords

Fluid therapy; Bolus

Outcome Measures

Primary Outcomes (1)

• MAP

  Mean arterial pressure

  15 minutes

Secondary Outcomes (45)

• MAP

  1 hour

• MAP

  2 hours

• SBP

  15 minutes

• SBP

  1 hour

• SBP

  2 hours

Study Arms (2)

Body temperature fluid bolus of crystalloid

ACTIVE COMPARATOR

Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes

Other: Body temperature; Drug: Fluid bolus

Room temperature fluid bolus of crystalloid

EXPERIMENTAL

Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes

Drug: Fluid bolus; Other: Room temperature

Interventions

Body temperature OTHER

Warming of administered fluid bolus

Body temperature fluid bolus of crystalloid

Fluid bolus DRUG

Administration of fluid bolus of crystalloid of 500ml over 15 minutes

Body temperature fluid bolus of crystalloid; Room temperature fluid bolus of crystalloid

Room temperature OTHER

Cooling of administered fluid bolus

Room temperature fluid bolus of crystalloid

Eligibility Criteria

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

You may qualify if:

• Admission to the ICU
• Age 18 years or older
• Clinical decision to administer a fluid bolus of at least 500 ml of crystalloid over 15 minutes.
• Monitoring with either an arterial line in an extremity that can be used for pulse contour analysis (Vigileo, FloTrac or equivalent system) or a central venous catheter and a femoral arterial line that can be used for pulse contour analysis calibrated by thermodilution (EV1000, PiCCO or equivalent system)
• At least one of the following criteria for fluid administration must be met:
• MAP \< 65 mmHg
• HR \>100
• Urine output \< 0,5ml/kg/h
• Lactate levels of \> 3 mmol/l
• CI \< 2.5L/min/m2
• SVV or PPV \> 12% if mechanically ventilated with tidal volumes \> 7 ml/kg
• ScvO2 or SvO2 \< 65%

You may not qualify if:

• Active bleeding requiring transfusion
• Haemoglobin level \<70 g/L
• Arrhythmia disturbing monitoring of cardiac output
• Patients in whom death is considered imminent (within 24 hours)
• CRRT
• Known pregnancy
• Active temperature control, either active warming or cooling
• Medical issue of pathological thermoregulation, such as malignant hyperthermia, thyroid storm, NMDA overdose, serotonin syndrome, malignant neuroleptic syndrome, or delirium.
• Planned exit from the ICU during the 2-hour monitoring period (planned surgical procedure, radiology, change of department etc.)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Danderyd Hospital: collaborator
• Stockholm South General Hospital: collaborator

Study Sites (2)

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Danderyds sjukhus

Stockholm, 182 57, Sweden

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Edema

Interventions

Body Temperature

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena

Study Officials

• Maria Cronhjort, MD, PhD

  maria.cronhjort@ki.se

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators will be blinded during analysis but unblinded during study performance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: RCT, unblinded

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: October 6, 2020
• Study Start: April 30, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)