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Completed

NCT Number: NCT01590511

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: baseline; 26 minutes

Secondary outcomes

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

    Time frame: baseline; 15 minutes

  2. Change in heart rate after the "mini-fluid challenge"

    Time frame: baseline; 26 minutes

    (bpm,%)

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

    Time frame: baseline; 26 minutes

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

    Time frame: baseline; 26 minutes

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

    Time frame: baseline; 26 minutes

  6. Change in the Marbrure clinical score after the "mini-fluid challenge"

    Time frame: baseline; 26 minutes

  7. Change in lower vena cava diameter

    Time frame: baseline; 8 minutes

    (DiameterMax-DiameterMin) / DiameterMax (cm;%)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: IVT NonVent

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 3, 2012
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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