Measurement of Serum Potassium Rate During Accidental Hypothermia.

Cardiac Arrest Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096561
• Other study ID #: N° ID-RCB: 2016-A01762-49
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2017
• Last updated: March 24, 2017
• Start date: November 14, 2016
• Est. completion date: July 2019

Study information

• Verified date: March 2017
• Source: University Hospital, Grenoble
• Contact: Marc Blancher, MD
• Phone: +33 (0) 476634266
• Email: MBlancher[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Accidental Hypothermia
• Cardiac Arrest
• Heart Arrest
• Hyperkalemia
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Vaudois	Lausanne	Valais
Switzerland	Hospital of Valais	Sion	Valais

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Department of Anesthesiology and Intensiv Care, University Hospital Grenoble Alps, Grenoble, Emergency Department, Hospital of Valais, Sion, Emergency Department, University Hospital Grenoble Alps, Grenoble, Emergency Department, University Hospital Vaudois, Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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