Mechanisms of Ultra-acute Hyperglycemia After Successful... | NCT01968148

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

NCT01968148

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Mar 13, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Heart Arrest
Cardiac Arrest

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jul 30, 2015Actual

Completion Date

Jul 30, 2015Actual

First Submitted Date

Oct 19, 2013

First Submission Date that Met QC Criteria

Oct 22, 2013

First Posted Date

Oct 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2018

Last Update Posted Date

Mar 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jouni Nurmi, MD, MD, PhD, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in level of insulin		60 minutes
Change in level of glucagon		60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Blood cortisol level		60 minutes after ROSC
Blood interleukin-6 level		60 minutes after ROSC
Change in blood glucose level

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jouni Nurmi, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki Emergency Medical Services		Helsinki			Finland
Helsinki Area Helicopter Emergency Medical Services

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided