NCT02142985

Brief Summary

Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult in some situations and need to be confirmed with other investigations. Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

May 6, 2014

Last Update Submit

April 29, 2021

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • central venous oxygen saturation (ScvO2) variation

    the ScvO2 is first measured at baseline via a central venous catheter and blood gaz, then after vascular filling (500 ml of colloid solution (Plasmagel) over thirty minutes).

    at baseline and after 10 minutes

Study Arms (1)

crystalloid solution

EXPERIMENTAL

vascular filling with 500 ml of crystalloid solution within 10 minutes

Drug: Sodium Chloride 0.9% Intravenous

Interventions

Sodium Chloride 0.9% IntravenousDRUG

vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes

crystalloid solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged above 18 year old
  • hemodynamic instability (hypotension or shock)

You may not qualify if:

  • intra cardiac shunt
  • severe arrythmia
  • valvular regurgitation
  • pacemaker
  • pulmonary oedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, 6000, Tunisia

Location

Related Publications (1)

  • Khalil MH, Sekma A, Zhani W, Zorgati A, Ben Soltane H, Nouira S; GREAT Network. Variation in central venous oxygen saturation to assess volume responsiveness in hemodynamically unstable patients under mechanical ventilation: a prospective cohort study. Crit Care. 2021 Jul 13;25(1):245. doi: 10.1186/s13054-021-03683-6. No abstract available.

    PMID: 34256822DERIVED

Related Links

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Nouira Samir, Professor

    Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 20, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

TU(1)