Measurement of Serum Potassium Rate During Accidental Hypothermia.

NCT ID: NCT03096561

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Accidental Hypothermia Hyperkalemia Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypothermia related cardiac arrest

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)

Group Type OTHER

blood draw from three different vessels

Intervention Type DIAGNOSTIC_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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood draw from three different vessels

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Grenoble Alps

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

Emergency Department, Hospital of Valais, Sion

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Vaudois

Lausanne, Valais, Switzerland

Site Status RECRUITING

Hospital of Valais

Sion, Valais, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marc Blancher, MD

Role: CONTACT

+33 (0) 476634266

Sarah K Buse

Role: CONTACT

+49 (0) 15201911437

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mathieu Pasquier, MD

Role: primary

+41 (0)21 314 55 90

Matthieu de Riedmatten, MD

Role: primary

0041(0)793773628

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31842931 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N° ID-RCB: 2016-A01762-49

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ICU Norepinephrine Load
NCT05032261 COMPLETED
Lactate in Cardiac Arrest
NCT02352350 WITHDRAWN