Kinetics of the Sublingual Microcirculation During Fluid Bolus

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675725
• Other study ID #: nWMO 128
• Status: Completed
• First received: January 8, 2016
• Last updated: March 26, 2018
• Start date: November 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: March 2017
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years old

• post-cardiac surgery and need for fluid therapy

Exclusion Criteria:

• recent maxillofacial surgery

Related Conditions & MeSH terms

• Hypovolemia
• Hypovolemic Shock
• Shock
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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