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The effect of rapid versus slow fluid therapy in ICU patients with severe infection

The hemodynamic and physiological effects of rapid versus slow fluid bolus therapy with 4% albumin in ICU patients with severe sepsis or septic shock

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001749291
Enrollment
68
Registered
2018-10-24
Start date
2019-03-01
Completion date
2020-03-02
Last updated
2018-11-12

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

Conditions

None listed

Brief summary

This research aims to compare the effect of rapid versus slow fluid therapy in ICU patients with severe infection. In this study, we plan to randomly allocate 68 critically ill ICU patients to receive either rapid or slow fluid infusion therapy and measure parameters associated with blood circulation. We hypothesize that slow fluid therapy will lead to a greater increase in overall output from the heart, blood pressure, as well as other indicators of blood volume expansion,compared to those after rapid infusion.

Interventions

The intervention is intravenous infusion of 4% Albumin. There will be two arms in this trial, where the participants will be randomised to either: 1. Rapid Fluid Therapy Group (active control group) 10mL/kg of 4% Albumin is given at 100mL/min. 2. Slow Fluid Therapy Group (experimental group) 10mL/kg of 4% Albumin is given at 10mL/min. The expected duration of the therapy is anywhere from 5 minutes to 120minutes. Above interventions will be performed and monitored closely by experienced ICU

The intervention is intravenous infusion of 4% Albumin. There will be two arms in this trial, where the participants will be randomised to either: 1. Rapid Fluid Therapy Group (active control group) 10mL/kg of 4% Albumin is given at 100mL/min. 2. Slow Fluid Therapy Group (experimental group) 10mL/kg of 4% Albumin is given at 10mL/min. The expected duration of the therapy is anywhere from 5 minutes to 120minutes. Above interventions will be performed and monitored closely by experienced ICU research nurse, who will use infusion pump or manual method to run the fluids intravenously at the bedside. The nurses will also ensure the fidelity of the interventions throughout the duration of therapy. The intervention will not involve any more invasive procedures to the patient who is already admitted in ICU.

Sponsors

Taeseon Shin
Lead SponsorIndividual

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
No

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

• Evidence of fluid overload or acute pulmonary edema • Patient has contraindications to receiving albumin (e.g., allergic reaction or Jenovah’s Witness) • Active bleeding requiring transfusion • Haemoglobin level <70g/L • Patients in whom death is considered imminent (within 24 hours) • Receiving continuous renal replacement therapy (CRRT) or hemodialysis • Pregnancy • Expected discharge from ICU during 2 hour monitoring period • Inability to give consent or refusing to consent • Inability to obtain satisfactory echocardiographic images for cardiac output measurement

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026