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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
Sponsor:
Collaborators:
University Grenoble Alps
Emergency Department, University Hospital Vaudois, Lausanne
Emergency Department, Hospital of Valais, Sion
Information provided by (Responsible Party):
University Hospital, Grenoble

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : November 14, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. Study of biological parameters to calculate the Strong Ion Gap (measured in mEq/l) according to the Stewart Approach [ Time Frame: 24 hours ]
    1. For each sample, the apparent strong ion difference (SIDa) will be calculated as SIDa =(Na+ +K+ +Ca2+ +Mg2+)−(Cl− +Lac−)
    2. The amount of weak plasma acid (A−) will be calculated as:

      A− = [Alb] × (0.123 × pH − 0.631) + [PO4] × (0.309 × pH − 0.469)

    3. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Contact: Marc Blancher, MD +33 (0) 476634266 MBlancher@chu-grenoble.fr
Contact: Sarah K Buse +49 (0) 15201911437 sarah@drbuse.de

Locations
Switzerland
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    matderied@yahoo.fr   
Sponsors and Collaborators
University Hospital, Grenoble
University Grenoble Alps
Emergency Department, University Hospital Vaudois, Lausanne
Emergency Department, Hospital of Valais, Sion

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03096561     History of Changes
Other Study ID Numbers: N° ID-RCB: 2016-A01762-49
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Hypothermia
Heart Arrest
Hyperkalemia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs