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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590511
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date April 30, 2012
First Posted Date May 3, 2012
Last Update Posted Date December 4, 2015
Study Start Date January 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2013)
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2) [ Time Frame: baseline; 26 minutes ]
Original Primary Outcome Measures
 (submitted: May 2, 2012)
Change in the subaortic velocity time integral after 100cc of hydroxyethyl starch over 15 minutes (cm^2) [ Time Frame: baseline; 26 minutes ]
Change History Complete list of historical versions of study NCT01590511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 22, 2013)
  • Change if the subaortic velocity time integral after a passive leg raising trial (cm^2) [ Time Frame: baseline; 15 minutes ]
  • Change in heart rate after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
    (bpm,%)
  • Change in mean arterial pressure after the "mini-fluid challenge" (mmHg) [ Time Frame: baseline; 26 minutes ]
  • Change in mitral E wave (cm / s) after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in the E/A ratio after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in the Marbrure clinical score after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in lower vena cava diameter [ Time Frame: baseline; 8 minutes ]
    (DiameterMax-DiameterMin) / DiameterMax (cm;%)
Original Secondary Outcome Measures
 (submitted: May 2, 2012)
  • Change if the subaortic velocity time integral after a passive leg raising trial (cm^2) [ Time Frame: baseline; 15 minutes ]
  • Change in heart rate after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
    (bpm,%)
  • Change in mean arterial pressure after the "mini-fluid challenge" (mmHg) [ Time Frame: baseline; 26 minutes ]
  • Change in mitral E wave (cm / s) after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in the E/A ratio after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in the Marbrure clinical score after the "mini-fluid challenge" [ Time Frame: baseline; 26 minutes ]
  • Change in lower veine cava diameter [ Time Frame: baseline; 8 minutes ]
    (DiameterMax-DiameterMin) / DiameterMax (cm;%)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
Official Title Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.
Condition
  • Shock
  • Circulatory Failure
Intervention Not Provided
Study Groups/Cohorts The study population
Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 3, 2015)
71
Original Estimated Enrollment
 (submitted: May 2, 2012)
70
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01590511
Other Study ID Numbers LOCAL/2012/XB-02
2012-A00500-43 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date December 2015