Comparison of 250 ml Versus 500 ml of Fluid Challenge

Comparison of 250 ml Versus 500 ml of Fluid Challenge on Oxygen Consumption in Critical Care Patients: an Open Label Multicentre Prospective Study

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Collaborator: Centre Hospitalier Universitaire Dijon

Source Centre Hospitalier Universitaire, Amiens
Brief Summary

The objective of fluid challenge is to increase oxygen delivery (DO2) in order to improve/restore tissue oxygen consuption (VO2). However the fluid challenge volume to administer stills in debate, some studies recommend to administer 250 mL. Previous studies suggested that 500 mL of fluid challenge administration may improve cardiac output and oxygen delivery. The relation between the amount of fluid expansion and oxygen delivery and oxygen consumption was not yet been studied in a randomized study in critical care patients. This is the purpose of this study.

Overall Status Not yet recruiting
Start Date March 2019
Completion Date March 2021
Primary Completion Date March 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
VO2 after fluid challenge 30 minutes after fluid challenge.
VO2 after fluid challenge 60 minutes after fluid challenge.
Secondary Outcome
Measure Time Frame
Change of arterial lactate concentration from baseline 30 minutes after fluid challenge.
Change of arterial lactate concentration from baseline 60 minutes after fluid challenge.
Cardiac output Immediately, 30 and 60 minutes after fluid challenge.
Respiratory variation of stroke volume Immediately, 30 and 60 minutes after fluid challenge.
PaO2/FiO2 Immediately, 30 and 60 minutes after fluid challenge.
Respiratory variation of the pulse pressure 30 and 60 minutes after fluid challenge.
Stroke volume variation with passive leg raising (PLV) 30 and 60 minutes after fluid challenge.
Systolic heart function (LVEF) Immediately, 30 and 60 minutes after fluid challenge.
Diastolic heart function Immediately, 30 and 60 minutes after fluid challenge.
Enrollment 172
Condition
Intervention

Intervention Type: Other

Intervention Name: Fluid challenge

Description: After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.

Eligibility

Criteria:

Inclusion Criteria:

- Patient for whom the physician in charge decided to infuse fluid challenge because of signs of acute circulatory failure (systolic arterial blood pressure < 90mmHg, and/or mean arterial blood pressure< 65 mmHg, and/or the need of vasopressive amine infusion, and/or skin motling, and/or diuresis <0.5 mL/kg/h for more than 2 hours, and/or arterial lactate level>2mmol/L.

- Echogenic patient

- Patient with a Stroke Volume (SV) variation with passive leg raising (PLR) more than 10%.

- Patient with regular sinus rythm.

- Patient who received protocol information.

Exclusion Criteria:

- Age Under 18-year-old.

- Pregnancy.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Osama Abou-Arab, Dr Principal Investigator CHU Amiens
Overall Contact

Last Name: Osama Abou-Arab, Dr

Phone: (33) 322087836

Email: [email protected]

Verification Date

March 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 250 mL of fluid challenge

Type: Active Comparator

Label: 500 mL of fluid challenge

Type: Experimental

Acronym KOBIAS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov