Kinetics of the Sublingual Microcirculation During Fluid Bolus

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Completed
CT.gov ID
NCT02675725
Collaborator
(none)
25
1
27.5
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Measurement of sublingual microcirculation with Cytocam-IDF camera

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.

Study Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Kinetics of the Sublingual Microcirculation During the Treatment of a Postoperative Shock
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Feb 15, 2018
Actual Study Completion Date :
Feb 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Post cardiac surgery

Patients after cardiac surgery with signs of decreased organ perfusion and the need of fluid therapy.

Device: Measurement of sublingual microcirculation with Cytocam-IDF camera
The normal treatment of a post-cardiac surgery patient is fluid bolus by indication. This indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. This fluid bolus is 250 ml crystalloids in 15 minutes. When this fluid bolus will be given, the investigators will observe the sublingual microcirculation and measure the red blood cell velocity and total vessel density on one spot for 20 minutes.

Outcome Measures

Primary Outcome Measures

  1. Change in Red blood cell velocity [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 Outcome Measures

  1. Change in Capillary vessel density [before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus]

    Offline analysis of the images made on known time points will provide a total vessel density change during the fluid bolus. Total vessel density: area of vessels divided by the total area of the image, mm/mm2.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years old

  • post-cardiac surgery and need for fluid therapy

Exclusion Criteria:
  • recent maxillofacial surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Centre Leeuwarden Leeuwarden Friesland Netherlands 8934 AD

Sponsors and Collaborators

  • Medical Centre Leeuwarden

Investigators

  • Principal Investigator: E.C. Boerma, MD-PhD, Medical Centre Leeuwarden

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gerke Veenstra, MD, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT02675725
Other Study ID Numbers:
  • nWMO 128
First Posted:
Feb 5, 2016
Last Update Posted:
Mar 27, 2018
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2018