Kinetics of the Sublingual Microcirculation During Fluid Bolus

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Hypovolemic Shock
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medical Centre Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Postoperative cardiac surgery patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• recent maxillofacial surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Red blood cell velocity	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)	before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Capillary vessel density	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.	before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pranskunas A, Koopmans M, Koetsier PM, Pilvinis V, Boerma EC. Microcirculatory blood flow as a tool to select ICU patients eligible for fluid therapy. Intensive Care Med. 2013 Apr;39(4):612-9. doi: 10.1007/s00134-012-2793-8. Epub 2012 Dec 20.
• Veenstra G, Ince C, Boerma EC. Direct markers of organ perfusion to guide fluid therapy: when to start, when to stop. Best Pract Res Clin Anaesthesiol. 2014 Sep;28(3):217-26. doi: 10.1016/j.bpa.2014.06.002. Epub 2014 Jul 15.
• van Genderen ME, Klijn E, Lima A, de Jonge J, Sleeswijk Visser S, Voorbeijtel J, Bakker J, van Bommel J. Microvascular perfusion as a target for fluid resuscitation in experimental circulatory shock. Crit Care Med. 2014 Feb;42(2):e96-e105. doi: 10.1097/CCM.0b013e3182a63fbf.
• Xu J, Ma L, Sun S, Lu X, Wu X, Li Z, Tang W. Fluid resuscitation guided by sublingual partial pressure of carbon dioxide during hemorrhagic shock in a porcine model. Shock. 2013 Apr;39(4):361-5. doi: 10.1097/SHK.0b013e31828936aa.
• Ince C. The rationale for microcirculatory guided fluid therapy. Curr Opin Crit Care. 2014 Jun;20(3):301-8. doi: 10.1097/MCC.0000000000000091.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Hypovolemia
• Other Study ID Numbers: nWMO 128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No