Measurement of Serum Potassium Rate During Accidental Hypothermia. (Kai+)
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|ClinicalTrials.gov Identifier: NCT03096561|
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : March 30, 2017
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||November 14, 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||July 2019|
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
- Comparison of potassium rate in central venous blood and blood from a peripheral vein (measured in mmol/l) [ Time Frame: 24 hours ]Comparison of PR in central venous blood and blood from a peripheral vein (measured in mmol/l)
- Comparison of potassium rate in venous and arterial blood (measured in mmol/l) [ Time Frame: 24 hours ]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) [ Time Frame: 24 hours ]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) [ Time Frame: 24 hours ]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 [ Time Frame: 3 months ]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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096561
|Contact: Marc Blancher, MD||+33 (0) 476634266||MBlancher@chu-grenoble.fr|
|Contact: Sarah K Buse||+49 (0) firstname.lastname@example.org|
|University Hospital Vaudois||Recruiting|
|Lausanne, Valais, Switzerland, 1011|
|Contact: Mathieu Pasquier, MD +41 (0)21 314 55 90 Mathieu.Pasquier@chuv.ch|
|Hospital of Valais||Recruiting|
|Sion, Valais, Switzerland, 1951|
|Contact: Matthieu de Riedmatten, MD 0041(0)793773628 email@example.com|