Kai+: Measurement of Serum Potassium Rate During Accidental Hypothermia.

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03096561
• Collaborator: University Grenoble Alps (Other), Emergency Department, University Hospital Vaudois, Lausanne (Other), Emergency Department, Hospital of Valais, Sion (Other)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 31.5
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Accidental Hypothermia; Hyperkalemia; Cardiac Arrest	Diagnostic Test: blood draw from three different vessels	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Comparative Study of Serum Potassium Rate Between Peripheral and Central Venous Sample Collection in Patients With Hypothermia Related Cardiac Arrest
• Actual Study Start Date: Nov 14, 2016
• Anticipated Primary Completion Date: Mar 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comparison of potassium rate in central venous blood and blood from a peripheral vein (measured in mmol/l) [24 hours]

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

Secondary Outcome Measures

1. Comparison of potassium rate in venous and arterial blood (measured in mmol/l) [24 hours]

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

2. Comparison of potassium rate from laboratory analysis and at bedside via blood gas analyser (measured in mmol/l) [24 hours]

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

3. Comparison of the time difference between laboratory analysis and blood gas analyzer at bed side (measured in minutes) [24 hours]

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

4. Survival and neurological outcome as measured by the Cerebral Performance Category Scale [3 months]

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

5. Study of biological parameters to calculate the Strong Ion Gap (measured in mEq/l) according to the Stewart Approach [24 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Vaudois	Lausanne	Valais	Switzerland	1011
2	Hospital of Valais	Sion	Valais	Switzerland	1951

Sponsors and Collaborators

• University Hospital, Grenoble
• University Grenoble Alps
• Emergency Department, University Hospital Vaudois, Lausanne
• Emergency Department, Hospital of Valais, Sion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03096561
• Other Study ID Numbers: N° ID-RCB: 2016-A01762-49
• First Posted: Mar 30, 2017
• Last Update Posted: Mar 30, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Arrest; Hyperkalemia; Hypothermia

Study Results

No Results Posted as of Mar 30, 2017