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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03066375
Other study ID # 2011_46
Secondary ID 2011-A01598-33
Status Completed
Phase N/A
First received November 9, 2016
Last updated February 27, 2017
Start date May 2012
Est. completion date June 2015

Study information

Verified date February 2017
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: To investigate whether respiratory variations of inferior vena cava diameters (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute circulatory failure and irregular heartbeats.

Design: Prospective, bicentric study, intensive care units.

Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of acute circulatory failure are included. A positive response to fluid loading (FL) is defined as an increase of the stroke volume (SV) >10%. The investigators measured the minimum inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before a 500ml-colloid FL.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients of the intensive care units of the Lille university-hospital and of the Valencienne general hospital.

- Age greater than or equal to 18.

- Patient insured

- Spontaneous breathing without ventilatory support or intubation or tracheotomy.

- Irregular cardiac rhythm

- Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.

- Patients with sepsis with at least one sign of acute circulatory failure:

- Tachycardia with heart rate> 100/min

- systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient

- Oliguria <0.5ml/kg/hour for at least one hour

- skin mottling

Exclusion Criteria:

- high-grade aortic insufficiency

- transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters

- clinical signs of active exhalation

- clinical or ultrasonographic evidence of pulmonary edema due to heart failure

- pregnancy

- abdominal compartment syndrome

- regular cardiac rhythm

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Echocardiography-Doppler
Ultrasonographic recordings are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles.

Locations

Country Name City State
France Intensive Care Department, Salengro Hospital,CHRU Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve during 30 minutes of the volume expansion
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