Kinetics of the Sublingual Microcirculation During Fluid Bolus

NCT02675725 | Completed

• 1 other identifier: nWMO 128
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Hypovolemic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (1)

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

Interventions

Measurement of sublingual microcirculation with Cytocam-IDF camera 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.

Post cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postoperative cardiac surgery patients

You may qualify if:

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

You may not qualify if:

• recent maxillofacial surgery

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 23263029 BACKGROUND

• 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.

  PMID: 25208957 BACKGROUND

• 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.

  PMID: 24158169 BACKGROUND

• 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.

  PMID: 23364438 BACKGROUND

• Ince C. The rationale for microcirculatory guided fluid therapy. Curr Opin Crit Care. 2014 Jun;20(3):301-8. doi: 10.1097/MCC.0000000000000091.

  PMID: 24758985 BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• E.C. Boerma, MD-PhD

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: February 5, 2016
• Study Start: November 1, 2015
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: March 27, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)