NCT01369524

Brief Summary

Although the investigators take many measurements to monitor the fluid state of the patients, it is not known exactly whether the fluid has real effect on the organ perfusion. The main focus of fluid is to improve the organ perfusion. Recent research has focused on the investigation of sublingual microcirculatory alterations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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

January 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
Last Updated

June 9, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

May 31, 2011

Last Update Submit

June 8, 2011

Conditions

Total Fluid Volume Increased

Keywords

fluid responsivenessmicrocirculationIntensive Care

Outcome Measures

Primary Outcomes (1)

  • correlation between change in microvascular flow index and fluid responsiveness - delta MFI before and after fluid challenge correlated to fluid responsiveness

    24 hours

Secondary Outcomes (1)

  • change in capillary density correlated to fluid responsiveness

    24 hours

Study Arms (1)

ICUpatient with need of fluid

age \> 18 - haemodynamic monitoring - informed consent - admission on ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted on the ICU and a need of fluids

You may qualify if:

  • age \> 18
  • hemodynamic monitoring
  • informed consent
  • admission on ICU

You may not qualify if:

  • no informed consent
  • oral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Study Officials

  • Christiaan Boerma, MD

    Frisius Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 9, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

June 9, 2011

Record last verified: 2011-05

Locations

NL(1)