Evaluation of Doppler Flow From the Femoral Artery as a Reflection of Cardiac Flow in a Vascular Fluid Test

NCT02878369 | Unknown

• 1 other identifier: RC13_0486
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In order to identify the responding patients with vascular filling test, this research aims to compare the performance of the increased flow in the femoral artery to the performance of the blood pressure increase. The reference measurement will increase cardiac output measured by ultrasound.

Conditions

Acute Circulatory Failure

Keywords

fluid replacement

Outcome Measures

Primary Outcomes (1)

• In the intensive care patient of acute circulatory failure signs, assess the increase of the femoral arterial flow (specifically its full-time speed, ΔRVAFitv measured by Doppler ultrasound) to identify responders this fluid replacement.

  First patient enrollment: april 2014 - Study duration: 24 month - Patient follow-up: 30 minutes

Interventions

Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor. PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred and twenty adult patients hospitalized in one of the participating ICUs, will be included (see the justification required number of subjects in "statistics") if * They are already carrying an intra-arterial catheter (femoral or radial). * They exhibit acute circulatory failure signs (see below) * The doctor in charge prescribed a vascular fluid replacement, regardless of the purposes of the study: * vascular fluid replacement * initiation or catecholamine * or increase (\> 10%) of catecholamine dosage.

You may qualify if:

• Patient hospitalized in intensive care and affiliated to a social security system
• Intra-arterial catheter already in place and operational
• Stability blood pressure for 5 min (no change in mean arterial pressure\> 10%, no increase in dose catecholamine)
• Presence of at least one sign of acute circulatory failure from:
• Low blood pressure (mean arterial pressure \<65 mmHg and / or systolic \<90 mmHg)
• tachycardia\> 120 bpm without other obvious cause a circulatory failure
• Oliguria \<1 ml / kg during the last hour suggestive of circulatory failure
• blood Hyperlactataemia\> 2 mmol / l without other obvious cause a systemic circulatory failure (lactate will not be measured for the purposes of the study)
• Smear
• ongoing catecholamine Administration
• Another sign justifying, according to the doctor in charge, vascular filling test (capillary refill time elongated, others ...)
• The doctor in charge has prescribed a fluid loading test, regardless of the needs of the study.
• Clear contraindication to the femoral artery Doppler (wound or burn the groin, for example)
• Complete occlusion of the femoral artery or 2 of the aorta requiring or having required a vascular bypass
• Pregnant woman

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Karim LAKHAL, Dr

CONTACT

lakhal_karim@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

FR (1)