Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest

This study is currently recruiting participants.
Verified January 2014 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Jouni Nurmi, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01968148
First received: October 19, 2013
Last updated: January 4, 2014
Last verified: January 2014
  Purpose

The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1).

Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples.

Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.


Condition
Heart Arrest
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Change in level of insulin [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Change in level of glucagon [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood cortisol level [ Time Frame: 60 minutes after ROSC ] [ Designated as safety issue: No ]
  • Blood interleukin-6 level [ Time Frame: 60 minutes after ROSC ] [ Designated as safety issue: No ]
  • Change in blood glucose level [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Change in level of GLP-1 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Successfully resuscitated patients treated by physician staffed mobile intensive care unit in Helsinki area.

Criteria

Inclusion Criteria:

  • age ≥18 years
  • witnessed cardiac arrest
  • interval form emergency call to return of spontaneous circulation 10-45 minutes

Exclusion Criteria:

  • severe pre-arrest disability leading to withdrawing treatment in prehospital phase
  • no concent from next of kin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968148

Contacts
Contact: Jouni Nurmi, MD, PhD +358505951576 jouni.nurmi@helsinki.fi

Locations
Finland
Helsinki Emergency Medical Services Recruiting
Helsinki, Finland
Contact: Ari Salo, MD    +35894711    ari.salo@hus.fi   
Helsinki Area Helicopter Emergency Medical Services Recruiting
Vantaa, Finland
Contact: Susanne Ångerman-Haasmaa, MD    +358 50 5818015    susanne.angerman-haasmaa@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Jouni Nurmi, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Jouni Nurmi, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01968148     History of Changes
Other Study ID Numbers: 357/13/03/12/2012 § 205
Study First Received: October 19, 2013
Last Updated: January 4, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
glucose
cardiac arrest
resuscitation
insulin
GLP-1

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014