Accidental HypothermiaKai+NCT03096561
Measurement of Serum Potassium Rate During Accidental Hypothermia.
A study testing blood draw from three different vessels in people with Accidental Hypothermia and Hyperkalemia, run by University Hospital, Grenoble at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Hypothermia, Hyperkalemia, Cardiac Arrest
- What is being tested?
- blood draw from three different vessels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 14 Nov 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypothermia related cardiac arrest
- Age > 18 years
- Core temperature < 30° C measured in oesophagus at hospital admission
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Vaudois
Lausanne, Valais, 1011
Mathieu Pasquier, MD, +41 (0)21 314 55 90, Mathieu.Pasquier@chuv.ch
- Recruiting
Hospital of Valais
Sion, Valais, 1951
Matthieu de Riedmatten, MD, 0041(0)793773628, matderied@yahoo.fr
About this study
Official title: A Comparative Study of Serum Potassium Rate Between Peripheral and Central Venous Sample Collection in Patients With Hypothermia Related Cardiac Arrest
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.
Read more
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.
- Conditions
- Accidental Hypothermia, Hyperkalemia, Cardiac Arrest
- Being tested
- blood draw from three different vessels
- Medical subject headings
- Hypothermia, Hyperkalemia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw from three different vesselsDiagnostic test
Patient in cardiac-arrest and cold exposure, diagnostic test: blood draw from three different vessels (central vein, artery, peripheral vein) and measuring of PR
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia related cardiac arrest | Other | 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) Receives: Diagnostic Test: blood draw from three different vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (5)
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)
Measured: 24 hours
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)
Measured: 24 hours
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)
Measured: 24 hours
Survival and neurological outcome as measured by the Cerebral Performance Category Scale
Survival and neurological outcome as measured by the Cerebral Performance Category Scale
Measured: 3 months
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start14 Nov 2016
- Primary completionMar 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental HypothermiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Centre Hospitalier Universitaire Vaudois, Emergency Department, Hospital of Valais, Sion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096561
- Sponsor's protocol ID
- N° ID-RCB: 2016-A01762-49
- Acronym
- Kai+
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31842931
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Serum Potassium Rate Between Peripheral and Central Venous Sample Collection in Patients With Hypothermia Related Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03096561
- Acronym / sponsor ID
- Kai+ / N° ID-RCB: 2016-A01762-49
- Conditions
- Accidental Hypothermia, Hyperkalemia, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Centre Hospitalier Universitaire Vaudois, Emergency Department, Hospital of Valais, Sion
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermia related cardiac arrest | Other | Diagnostic Test: blood draw from three different vesselsblood 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypothermia related cardiac arrest
- Age > 18 years
- Core temperature < 30° C measured in oesophagus at hospital admission
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw from three different vesselsPatient in cardiac-arrest and cold exposure, diagnostic test: blood draw from three different vessels (central vein, artery, peripheral vein) and measuring of PR | Diagnostic test | Hypothermia related cardiac arrest |
Primary outcome
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)
5 secondary outcomes
Comparison of potassium rate in venous and arterial blood (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)
Time frame: 24 hours
Comparison of the time difference between laboratory analysis and blood gas analyzer at bed side (measured in minutes)
Time frame: 24 hours
Survival and neurological outcome as measured by the Cerebral Performance Category Scale
Time frame: 3 months
Study of biological parameters to calculate the Strong Ion Gap (measured in mEq/l) according to the Stewart Approach
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Derived from this study: PubMed 31842931Pasquier 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.
- Individual participant dataSharing planned: No
Related trials for Accidental Hypothermia
RecruitingObservational study
Core Temperature in Patients With OHCA
Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia
Not yet recruiting
Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery
Elderly Patients, Cancer Surgery
Enrolling by invitation
Prehospital Use of Forced Air Warming
Hypothermia Due to Cold Environment
Enrolling by invitationObservational study
Constructing a Risk Prediction Model for Intraoperative Hypothermia in Children Under General Anesthesia
Hypothermia, Accidental, Hypothermia; Anesthesia
Enrolling by invitation
Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study
Accidental Hypothermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood draw from three different vessels in people with Accidental Hypothermia and Hyperkalemia, run by University Hospital, Grenoble at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Blancher, MD (+33 (0) 476634266, MBlancher@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of potassium rate in central venous blood and blood from a peripheral vein (measured in mmol/l) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.