NCT01630577

Brief Summary

We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

June 21, 2012

Last Update Submit

May 4, 2016

Conditions

Acute Circulatory Failure

Keywords

acute circulatory failurehemodynamic stabilityhypovolemia

Outcome Measures

Primary Outcomes (1)

  • fluid challange responsiveness

    change of Stroke volume variation (SVV) by more than 10%

    within 20 minutes of fluid challenge

Study Arms (1)

responder to fluid challenge

EXPERIMENTAL

fluid challenge

Other: volume expansion using modified gelatin

Interventions

volume expansion using modified gelatinOTHER

Volume expansion using modified gelatin was determined according to a procedure formulated by modifying guidelines produced by Weil and Henning. The maximum volume infusion during the study test was fixed at 400 ml.

Also known as: fluid challenge
responder to fluid challenge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanically ventilated patients
  • acute circulatory failure defined by the need of vasopressive drugs (dopamine \>5µg/kg/per minute or norepinephrine) with signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output below 0.5 ml per kilogram of body weight per hour during at least 2 h).
  • admission serum lactate level more than 2.5mmol/L

You may not qualify if:

  • severe hypoxemia defined as a ratio of arterial oxygen pressure to fraction of inspired oxygen \[PaO2/FiO2\] \< 100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Fattouma Bourguiba

Monastir, Monastir Governorate, 5000, Tunisia

Location

Emergency Department FB University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

Location

MeSH Terms

Conditions

ShockHypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nouira Semir, Professor

    FB University Hospital Monastir Tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 28, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

TU(2)