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Clinical Trials/NCT02675725
NCT02675725
Completed
Not Applicable

Kinetics of the Sublingual Microcirculation During the Treatment of a Postoperative Shock

Medical Centre Leeuwarden1 site in 1 country25 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Medical Centre Leeuwarden
Enrollment
25
Locations
1
Primary Endpoint
Change in Red blood cell velocity
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the shock.

The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy.

After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.

Detailed Description

Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that a fluid bolus will increase the delivery of oxygen to the cells and resolve the shock. The evaluation of this treatment is done by clinical signs of organ perfusion en (little used) invasive hemodynamic monitoring. Previous research suggests that in-vivo microscopy of the microcirculation can be of importance to determine the type of shock and the reaction on treatment on tissue level. Evaluation of the microcirculation was done by measuring red blood cell velocity on three different sites in the sublingual region. This was necessary in order to take heterogeneity into account, it was very hard to fix the camera on one spot during the observation period. The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. The great advantage is that the recordings before and after fluid therapy can be compared with each other as paired data, wherein the subject is its own control. By choosing a time interval that is long enough for the observation of the changes, but short enough for manual fixing of the camera, it seems possible to serve both purposes (15-30 minutes). This seems crucial now because both red blood cell flow as capillary density will be measured. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy. After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
February 15, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical Centre Leeuwarden
Responsible Party
Principal Investigator
Principal Investigator

Gerke Veenstra

MD

Medical Centre Leeuwarden

Eligibility Criteria

Inclusion Criteria

  • \> 18 years old
  • post-cardiac surgery and need for fluid therapy

Exclusion Criteria

  • recent maxillofacial surgery

Outcomes

Primary Outcomes

Change in Red blood cell velocity

Time Frame: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus

Measuring red blood cell velocity by using the microcirculatory blood flow index by eye-balling, (0: no flow; 1: stop-and-go; 2: sluggish; 3: normal flow)

Secondary Outcomes

  • Change in Capillary vessel density(before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus)

Study Sites (1)

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