Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects. (PORTEAU)

• ClinicalTrials.gov Identifier: NCT03589261
• Recruitment Status: Completed
• First Posted: July 17, 2018
• Last Update Posted: April 2, 2019
• Sponsor: Centre Hospitalier Universitaire, Amiens
• Information provided by (Responsible Party): Centre Hospitalier Universitaire, Amiens

Study Description

Brief Summary:

Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.

Condition or disease	Intervention/treatment	Phase
Hepatic Flow Changes	Device: MRI (magnetic resonance imaging)	Not Applicable

Detailed Description:

Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial
• Actual Study Start Date: September 6, 2018
• Actual Primary Completion Date: March 29, 2019
• Actual Study Completion Date: March 29, 2019

Arms and Interventions

Arm	Intervention/treatment
MRI (magnetic resonance imaging); Hepatic blood flow baseline will be measured using MRI. Fluid challenge of 500 ml of NaCl 0.9% will be administered during 10 minutes. Before and After fluid challenge, MRI will be performed to compare flow changes.	Device: MRI (magnetic resonance imaging); Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.; Other Name: 500 ml of intra venous NaCl (0.9%).

Outcome Measures

Primary Outcome Measures :

1. Portal blood flow measure before and after fluid challenge [ Time Frame: Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%. ]
   Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI (magnetic resonance imaging).

Secondary Outcome Measures :

1. Hepatic artery blood flow measure before and after fluid challenge [ Time Frame: Two hours ]
   Hepatic artery blood flow measure before and after a volume expansion of 500 ml NaCl 0.9%.

Other Outcome Measures:

1. Flow ratio of portal flow on hepatic artery flow [ Time Frame: Two hours ]
   Flow ratio of portal flow on hepatic artery flow before and after a volume expansion of 500 ml NaCl 0.9%.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Fasting for the last 12 hours.

Exclusion Criteria:

• Claustrophobia
• Any previous medical history disease;
• Any abdominal surgical disease
• Pregnancy or breastfeeding

Contacts and Locations

Locations

France

CHU Amiens-Picardie

Amiens, France, 80000

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

More Information

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03589261
• Other Study ID Numbers: PI2018_843_0006
• First Posted: July 17, 2018
• Last Update Posted: April 2, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No