NCT03096561

Brief Summary

Serum Potassium Rate (PR) is a key indicator for medical management of patients with accidental hypothermia particularly for hypothermia related cardiac arrest (CA). Experts recommend a cut-off value for PR of 12 mmol/l for all hypothermic victims and 8 mmol/l for avalanche casualties. Any patient presenting a PR lower than the cut-off value should be considered for Extracorporeal Rewarming. This therapeutic strategy is vital for patient survival. However, there is no consensus about what type of vessels should be punctured in order to obtain an accurate potassium rate and what type of measurement technics should be used to measure this potassium rate. The investigators hypothesize that potassium rate in these patients will differ by 1 mmol/l in blood samples collected from a peripheral vein in contrast to a central vein. The investigators study is a prospective observational, multicentre study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

March 16, 2017

Last Update Submit

March 24, 2017

Conditions

Accidental HypothermiaHyperkalemiaCardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Comparison of potassium rate in central venous blood and blood from a peripheral vein (measured in mmol/l)

    Comparison of PR in central venous blood and blood from a peripheral vein (measured in mmol/l)

    24 hours

Secondary Outcomes (5)

  • Comparison of potassium rate in venous and arterial blood (measured in mmol/l)

    24 hours

  • Comparison of potassium rate from laboratory analysis and at bedside via blood gas analyser (measured in mmol/l)

    24 hours

  • Comparison of the time difference between laboratory analysis and blood gas analyzer at bed side (measured in minutes)

    24 hours

  • Survival and neurological outcome as measured by the Cerebral Performance Category Scale

    3 months

  • Study of biological parameters to calculate the Strong Ion Gap (measured in mEq/l) according to the Stewart Approach

    24 hours

Study Arms (1)

Hypothermia related cardiac arrest

OTHER

blood draw from three different vessels punctured in the emergency room (central vein, peripheral vein, artery) and comparison of potassium rate and other biological values between the different sites of blood draw and two different measuring techniques (laboratory vs. blood gas analyser)

Diagnostic Test: blood draw from three different vessels

Interventions

blood draw from three different vesselsDIAGNOSTIC_TEST

Patient in cardiac-arrest and cold exposure, diagnostic test: blood draw from three different vessels (central vein, artery, peripheral vein) and measuring of PR

Hypothermia related cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypothermia related cardiac arrest
  • Age \> 18 years
  • Core temperature \< 30° C measured in oesophagus at hospital admission

You may not qualify if:

  • Age \< 18 years
  • Known condition of pregnancy or breastfeeding women
  • Evidence of trauma-related cardiac arrest
  • Cardiac arrest in which reanimation is not justified (frozen body, final stadium of an incurable disease, advance health care directive)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Vaudois

Lausanne, Valais, 1011, Switzerland

RECRUITING

Hospital of Valais

Sion, Valais, 1951, Switzerland

RECRUITING

Related Publications (1)

  • Pasquier M, Blancher M, Buse S, Boussat B, Debaty G, Kirsch M, de Riedmatten M, Schoettker P, Annecke T, Bouzat P. Intra-patient potassium variability after hypothermic cardiac arrest: a multicentre, prospective study. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):113. doi: 10.1186/s13049-019-0694-3.

    PMID: 31842931DERIVED

MeSH Terms

Conditions

HypothermiaHyperkalemiaHeart Arrest

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Marc Blancher, MD

CONTACT

+33 (0) 476634266MBlancher@chu-grenoble.fr

Sarah K Buse

CONTACT

+49 (0) 15201911437sarah@drbuse.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 30, 2017

Study Start

November 14, 2016

Primary Completion

March 1, 2019

Study Completion

July 1, 2019

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)