Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Microcirculatory Perfusion as Measured by Sublingual SDF Imaging and NIRS in Patients With Coma After Out-of-hospital Cardiac Arrest Treated With Mild Therapeutic Hypothermia (TH) or Not Treated With Mild-TH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850485
• Other study ID #: TPO 745
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: June 22, 2015
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.

Description:

The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• out-of-hospital cardiac arrest

• > 18 years

• informed consent

• ROSC (return of spontaneous circulation) < 4 hours

Exclusion Criteria:

• recent maxillofacial surgery

• participation in other clinical trials

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• microcirculation by SDF and NIRS, in 33 and 36 degrees
at baseline, after 12 and 24 hours in both arms

Locations

Country	Name	City	State
Netherlands	Medical Center Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular Flow Index (MFI)	Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)	baseline measurement	No
Secondary	RincStO2	tissue oxygenation measured by Near Infrared Spectroscopy	baseline	No
Secondary	Fluid Balance After 24 Hours		24 hours	No
Secondary	Inotropes and Vasopressor Dose		baseline	No
Secondary	Cardiac Index	Cardiac Index is cardiac output indexed for body weight	24 hours	No
Secondary	Lactate	lactate levels in serum	24 hours	No
Secondary	SvO2	(venous oxygen saturation)	24 hours	No