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

Primary Purpose

Accidental Hypothermia, Hyperkalemia, Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
blood draw from three different vessels
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Accidental Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital VaudoisRecruiting
  • Hospital of ValaisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hypothermia related cardiac arrest

Arm Description

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2017
Last Updated
March 24, 2017
Sponsor
University Hospital, Grenoble
Collaborators
University Grenoble Alps, Emergency Department, University Hospital Vaudois, Lausanne, Emergency Department, Hospital of Valais, Sion
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1. Study Identification

Unique Protocol Identification Number
NCT03096561
Brief Title
Measurement of Serum Potassium Rate During Accidental Hypothermia.
Acronym
Kai+
Official Title
A Comparative Study of Serum Potassium Rate Between Peripheral and Central Venous Sample Collection in Patients With Hypothermia Related Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University Grenoble Alps, Emergency Department, University Hospital Vaudois, Lausanne, Emergency Department, Hospital of Valais, Sion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Hypothermia, Hyperkalemia, Cardiac Arrest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypothermia related cardiac arrest
Arm Type
Other
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
blood draw from three different vessels
Intervention Description
Patient in cardiac-arrest and cold exposure, diagnostic test: blood draw from three different vessels (central vein, artery, peripheral vein) and measuring of PR
Primary Outcome Measure Information:
Title
Comparison of potassium rate in central venous blood and blood from a peripheral vein (measured in mmol/l)
Description
Comparison of PR in central venous blood and blood from a peripheral vein (measured in mmol/l)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comparison of potassium rate in venous and arterial blood (measured in mmol/l)
Description
Comparison of potassium rate in venous and arterial blood (measured in mmol/l)
Time Frame
24 hours
Title
Comparison of potassium rate from laboratory analysis and at bedside via blood gas analyser (measured in mmol/l)
Description
Comparison of potassium rate from laboratory analysis and at bedside via blood gas analyser (measured in mmol/l)
Time Frame
24 hours
Title
Comparison of the time difference between laboratory analysis and blood gas analyzer at bed side (measured in minutes)
Description
Comparison of the time difference between laboratory analysis and blood gas analyzer at bed side (measured in minutes)
Time Frame
24 hours
Title
Survival and neurological outcome as measured by the Cerebral Performance Category Scale
Description
Survival and neurological outcome as measured by the Cerebral Performance Category Scale
Time Frame
3 months
Title
Study of biological parameters to calculate the Strong Ion Gap (measured in mEq/l) according to the Stewart Approach
Description
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
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Blancher, MD
Phone
+33 (0) 476634266
Email
MBlancher@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah K Buse
Phone
+49 (0) 15201911437
Email
sarah@drbuse.de
Facility Information:
Facility Name
University Hospital Vaudois
City
Lausanne
State/Province
Valais
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Pasquier, MD
Phone
+41 (0)21 314 55 90
Email
Mathieu.Pasquier@chuv.ch
Facility Name
Hospital of Valais
City
Sion
State/Province
Valais
ZIP/Postal Code
1951
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu de Riedmatten, MD
Phone
0041(0)793773628
Email
matderied@yahoo.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31842931
Citation
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.
Results Reference
derived

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Measurement of Serum Potassium Rate During Accidental Hypothermia.

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