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

This study is currently recruiting participants.
Verified April 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01590511
First received: April 30, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Shock
Circulatory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2) [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change if the subaortic velocity time integral after a passive leg raising trial (cm^2) [ Time Frame: baseline; 15 minutes ] [ Designated as safety issue: No ]
  • Change in heart rate after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]
    (bpm,%)

  • Change in mean arterial pressure after the "mini-fluid challenge" (mmHg) [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]
  • Change in mitral E wave (cm / s) after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]
  • Change in the E/A ratio after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]
  • Change in the Marbrure clinical score after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ] [ Designated as safety issue: No ]
  • Change in lower vena cava diameter [ Time Frame: baseline; 8 minutes ] [ Designated as safety issue: No ]
    (DiameterMax-DiameterMin) / DiameterMax (cm;%)


Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
The study population
Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

Detailed Description:

The secondary objectives of this study include:

  • To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.
  • To study the inter-observer variation of ΔITV100 measurement.
  • To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590511

Contacts
Contact: Xavier Bobbia, MD +33.(0)4.66.68.30.50 xavier.bobbia@gmail.com
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Xavier Bobbia, MD            
Sub-Investigator: Eric Vernes, MD            
Sub-Investigator: Romain Genre Grandpierre, MD            
Sub-Investigator: Stéphane Pommet, MD            
Sub-Investigator: Alexandre Moreau, MD            
Sub-Investigator: Laurent Muller, MD            
Sub-Investigator: Pascal Jeannes, MD            
Sub-Investigator: Guillaume Louart, MD            
Sub-Investigator: Claire Roger, MD            
Sub-Investigator: Saber Barbar, MD            
Sub-Investigator: Caroline Boutin, MD            
Sub-Investigator: Christian Bengler, MD            
Sub-Investigator: Geoffroy Dingemans, MD            
Sub-Investigator: Benjamin Louart, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01590511     History of Changes
Other Study ID Numbers: LOCAL/2012/XB-02, 2012-A00500-43
Study First Received: April 30, 2012
Last Updated: April 22, 2013
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
mini fluid challenge
subaortic velocity time integral

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013