Hemodynamic effects of warm vs cold resuscitation fluid in critically ill patients

A randomized control study to examine the hemodynamic effects of resuscitation fluid temperature (warm vs room temperature) in critically ill patients

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001644257

Enrollment

Registered

2018-10-04

Start date

2019-02-04

Completion date

2020-08-03

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Low blood pressure is a common problem in critically ill patients. It is often associated with compromised organ blood flow, leading to organ dysfunction. Administration of fluids into a vein is a common method to treat low blood pressure, which aims to increase blood volume to improve organ blood flow. The effect of fluid temperature on blood pressure and cardiac output is largely unknown. In healthy volunteers, it was found that room temperature fluids led to a bigger increase in blood pressure than warmed fluids, but caused a decrease in cardiac output. This was thought to be due to reflexive constriction of blood vessels in response to cold. A decrease in cardiac output may in turn cause lowered organ blood flow. This study aims to compare the effect of room temperature and warmed fluid therapy on cardiac output and blood pressure, in critically ill patients. We postulate warmed fluids may lead to better increase in cardiac output, compared to room temperature fluids. If this is true, warmed fluid therapy may become standard to improve organ blood flow in critically ill patients.

Interventions

Intensive Care patients meeting a predetermined criteria to receive a fluid bolus will be randomised into intervention (warmed) or control (room temperature) groups. Patients in intervention group will receive a 500ml bolus of 4% albumin intravenously over 15 minutes, given through a fluid warmer at 38 degrees Celsius.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Admitted to ICU • Age 18 years or older • Meeting clinical criteria for fluid bolus administration (one of the following): o MAP <65mmHg o HR >100bpm o Urine output <0.5ml/kg/hr o Lactate levels of >3mmol/dL o Cardiac index <2.5L/min/m2

Exclusion criteria

• Active bleeding requiring transfusion • Haemoglobin level <70g/L • Patients in whom death is considered imminent (within 24 hours) • Receiving continuous renal replacement therapy (CRRT) • Active temperature control • Pregnancy • Malignant hyperthermia • Planned exit from ICU during 2 hour monitoring period • Inability to obtain satisfactory echocardiographic images for cardiac output measurement

Outcome results