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

Not Applicable

• Conditions: sepsis; Infection - Other infectious diseases

• Registration Number: ACTRN12618001749291
• Lead Sponsor: Taeseon Shin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-24
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

•Admitted to ICU
•Age 18 years or older
•Meeting clinical criteria for fluid bolus administration (one of the following):
oMAP <65mmHg
oHR >100bpm
oUrine output <0.5ml/kg/hr
oLactate levels of >3mmol/dL
oCardiac 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke Work measured by Echocardiography machine (non-invasive ultrasound machine). [Measured at every 30 minutes after the completion of fluid therapy (given either rapidly or slowly) for 2 hours duration (i.e., 30min, 60min, 90min, and 120min after the completion of fluid infusion). Primary endpoint will be the calculated mean value of all the measured data. ]

Secondary Outcome Measures

Name	Time	Method
Stroke Volume measaured using Echocardiography machine.<br>[Stroke volume is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion), ];Blood pressure, both systolic and mean arterial pressure will be measured via arterial line monitoring device <br>[Blood pressure is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion),];Heart Rate measured by 3 lead ECG [Heart Rate is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion). <br> <br><br>];Lactate measured by taking arterial blood gas sample and running the serum assay [Lactate is measured at 15min, 30min, 45min, 60min, 90min, and 120min after the completion of fluid infusion. ];Urine output measured by the bedside nurse by checking urine drainge bag [Urine output is measured at every 15 minutes after the completion of the fluid therapy. ]