Comparison of 250 ml Versus 500 ml of Fluid Challenge

NCT ID: NCT03874923

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-08-30

Brief Summary

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The objective of fluid challenge is to increase oxygen delivery (DO2) in order to improve/restore tissue oxygen consumption (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.

Detailed Description

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Conditions

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Fluid Challenge Oxygen Consumption Critical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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250 mL of fluid challenge

Group Type ACTIVE_COMPARATOR

Fluid challenge

Intervention Type OTHER

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.

500 mL of fluid challenge

Group Type EXPERIMENTAL

Fluid challenge

Intervention Type OTHER

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.

Interventions

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Fluid challenge

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.

Intervention Type OTHER

Eligibility Criteria

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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 mottling, 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 rhythm.
* Patient who received protocol information.

Exclusion Criteria

* Age Under 18-year-old.
* Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osama Abou-Arab, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens Picardie

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0034

Identifier Type: -

Identifier Source: org_study_id

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