Kinetics of the Sublingual Microcirculation During Fluid Bolus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

NCT01866657

Hypoxia

TERMINATED NA

Cerebral Oximeter Comparison Study

NCT01655940

Cardiac Bypass Patients

COMPLETED

Assessment of Cerebral Microvascular Circulation

NCT02179840

Cerebral Microvascular Circulation

WITHDRAWN NA

Non Invasive Neuromonitoring After Cardiac Arrest

NCT02575196

Cardiac Arrest

COMPLETED

The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure

NCT02060825

Congenital Heart Disease

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Hypovolemic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Post cardiac surgery

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

Measurement of sublingual microcirculation with Cytocam-IDF camera

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE