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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014