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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04260841
Other study ID # nWMO 217
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date November 1, 2019

Study information

Verified date February 2020
Source Medical Centre Leeuwarden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.


Description:

PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- admission on Intensive Care

- clinical signs as; mean arterial pressure < 60, lactate > 2.0 mmol/L

Exclusion Criteria:

- age < 18

Study Design


Related Conditions & MeSH terms


Intervention

Device:
bed in 45 degrees for passive leg raising test
fluid responsiveness is tested by the passive leg raising test

Locations

Country Name City State
Netherlands Medical Center Leeuwarden Leeuwarden

Sponsors (1)

Lead Sponsor Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary fluid responsiveness expressed in volume are both PLR tests similar / comparable on fluid responsiveness from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
Primary blood pressure expressed in mmHg are both PLR tests similar / comparable on fluid responsiveness test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
Primary cardiac output are both PLR tests similar / comparable on fluid responsiveness test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
See also
  Status Clinical Trial Phase
Recruiting NCT06423833 - Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients N/A