Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

NCT01590511 | Completed

• 2 other identifiers: LOCAL/2012/XB-022012-A00500-43
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

Conditions

Shock; Circulatory Failure

Keywords

mini fluid challenge; subaortic velocity time integral

Outcome Measures

Primary Outcomes (1)

• Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)

  baseline; 26 minutes

Secondary Outcomes (7)

• Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)

  baseline; 15 minutes

• Change in heart rate after the "mini-fluid challenge"

  baseline; 26 minutes

• Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)

  baseline; 26 minutes

• Change in mitral E wave (cm / s) after the "mini-fluid challenge"

  baseline; 26 minutes

• Change in the E/A ratio after the "mini-fluid challenge"

  baseline; 26 minutes

Study Arms (1)

The study population

Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• Systolic blood pressure (SBP) \< 90 mmHg
• Signs of inadequate cardiac output: urine output \<0.5 ml / kg / h for more than two hours, hyperlactataemia
• Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient (or his/her person-of-trust) refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patients has a contraindication for a treatment necessary for this study
• Cardiogenic shock
• Acute pulmonary edema
• Moribund patient
• Non echogenic patient
• Patient with cardiac arrhythmia
• Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier Bobbia, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 3, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

FR (1)