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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 4, 2014
Last verified: March 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 4, 2014
Health Authority: France: 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 September 16, 2014