Measurement of Serum Potassium Rate During Accidental Hypothermia. (Kai+)

A Comparative Study of Serum Potassium Rate Between Peripheral and Central Venous Sample Collection in Patients With Hypothermia Related Cardiac Arrest

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest; Hyperkalemia; Accidental Hypothermia
• Intervention / Treatment: Diagnostic test: blood draw from three different vessels

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Valais
    • Lausanne, Valais, Switzerland, 1011
      • Recruiting
      • University Hospital Vaudois
      • Contact: Mathieu Pasquier, MD; Phone Number: +41 (0)21 314 55 90; Email: Mathieu.Pasquier@chuv.ch
    • Sion, Valais, Switzerland, 1951
      • Recruiting
      • Hospital of Valais
      • Contact: Matthieu de Riedmatten, MD; Phone Number: 0041(0)793773628; Email: matderied@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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)	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of potassium rate in venous and arterial blood (measured in mmol/l)	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)	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)	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	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	For each sample, the apparent strong ion difference (SIDa) will be calculated as SIDa =(Na+ +K+ +Ca2+ +Mg2+)-(Cl- +Lac-); The amount of weak plasma acid (A-) will be calculated as:A- = [Alb] × (0.123 × pH - 0.631) + [PO4] × (0.309 × pH - 0.469); The effective strong ion difference (SIDe) will be calculated as: SIDe = 1000 × 2.46 × 10-11 × PaCO2/(10-pH) + [A-] To quantify unmeasured charges, the SIG will be calculated as: SIG = SIDa - SIDe	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Grenoble Alps; Emergency Department, University Hospital Vaudois, Lausanne; Emergency Department, Hospital of Valais, Sion

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2016
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Body Temperature Changes; Water-Electrolyte Imbalance; Heart Arrest; Hypothermia; Hyperkalemia
• Other Study ID Numbers: N° ID-RCB: 2016-A01762-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No