Evidence map›Paper›PMID 30343315›Full record

Trial reportIntensive care medicine2018

A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial.

Esteban Lopez-de-Sa, Miriam Juarez, Eduardo Armada, José C Sanchez-Salado, Pedro L Sanchez, Pablo Loma-Osorio, Alessandro Sionis, Maria C Monedero, Manuel Martinez-Sellés, Juán C Martín-Benitez and 8 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Intensive care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02035839 (A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.), which is not on this map. Cited by 31 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02035839 nacompletednot on this map

A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.

TypeinterventionalSponsorZOLL Circulation, Inc., USARan2014 to 2016Enrolled150ConditionsOut-Of-Hospital Cardiac ArrestArmsTarget Temperature Management of 34°C, Target Temperature Management of 32°C, Target Temperature Management of 33°C
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Hypothermia for neuroprotection in adults after cardiac arrest.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Guideline
  9. Trial
  10. Review
  11. Review
  12. Management of non-Cardiac Organ Failure in cardiogenic shock.American heart journal plus : cardiology research and practice · 2025
    Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Through the Looking Glass: The Paradoxical Evolution of Targeted Temperature Management for Comatose Survivors of Cardiac Arrest.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Esteban Lopez-de-SaAcute Cardiac Care Unit, Cardiology Department, Hospital Universitario La Paz, IdiPaz. CIBERCV, Paseo de La Castellana, 261, 28046, Madrid, Spain. e.lopezdesa@gmail.com.ORCID http://orcid.org/0000-0002-3504-6901
Miriam JuarezCardiology Department, Hospital Universitario Gregorio Marañón. CIBERCV, Calle Dr Esquerdo, 46, 28007, Madrid, Spain.
Eduardo ArmadaAcute Cardiac Care Unit, Cardiology Department, Hospital Universitario La Paz, IdiPaz. CIBERCV, Paseo de La Castellana, 261, 28046, Madrid, Spain.
José C Sanchez-SaladoCardiology Department, Hospital Universitario de Bellvitge, Carrer Prínceps d'Espanya s/n, L'Hospitalet de Llobregat, 08902, Barcelona, Spain.
Pedro L SanchezCardiology Department, Hospital Universitario de Salamanca, Paseo de San Vicente, 58-182, 37007, Salamanca, Spain.
Pablo Loma-OsorioCardiology Department, Hospital Universitario Josep Trueta, Avenida França, s/n, 17007, Girona, Spain.
Alessandro SionisIntensive Cardiac Care Unit, Cardiology Department, Hospital de Sant Pau. IIB-Sant Pau. CIBERCV, Universitat Autònoma de Barcelona, Calle de San Quintín, 89, 08026, Barcelona, Spain.
Maria C MonederoAcute Cardiac Care Unit, Cardiology Department, Hospital Universitario La Paz, IdiPaz. CIBERCV, Paseo de La Castellana, 261, 28046, Madrid, Spain.
Manuel Martinez-SellésCardiology Department, Hospital Universitario Gregorio Marañón. CIBERCV, Calle Dr Esquerdo, 46, 28007, Madrid, Spain.
Juán C Martín-BenitezIntensive Care Department, Hospital Clínico San Carlos, Calle Profesor Martin Lagos, 2, 28040, Madrid, Spain.
Albert ArizaCardiology Department, Hospital Universitario de Bellvitge, Carrer Prínceps d'Espanya s/n, L'Hospitalet de Llobregat, 08902, Barcelona, Spain.
Aitor UribarriCardiology Department, Hospital Universitario de Salamanca, Paseo de San Vicente, 58-182, 37007, Salamanca, Spain.
José M Garcia-AcuñaCardiology Department, Complejo Hospitalario Universitario de Santiago. CIBERCV, Travesía Da Choupana S/N, Santiago de Compostela, La Coruña, 15706, Spain.
Patricia VillaIntensive Care Department, Hospital Universitario Principe de Asturias, Carretera. Alcalá-Meco, s/n, Alcalá de Henares, 28805, Madrid, Spain.
Pablo J PerezCardiology Department, Hospital Universitario de Canarias, Calle Ofra S/N, San Cristóbal de La Laguna, 38320, Santa Cruz de Tenerife, Spain.
Christian StormDepartment of Internal Medicine, Nephrology and Intensive Care, Charité-Universitätsmedizin, Charitéplatz 1, 10117, Berlin, Germany.
Anne DeeBiostatistics Department, ZOLL Medical Corporation, 2000 Ringwood Ave, San Jose, CA, 95131, USA.
Jose L Lopez-SendonAcute Cardiac Care Unit, Cardiology Department, Hospital Universitario La Paz, IdiPaz. CIBERCV, Paseo de La Castellana, 261, 28046, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo obtain initial data on the effect of different levels of targeted temperature management (TTM) in out-of-hospital cardiac arrest (OHCA).

methodsWe designed a multicentre pilot trial with 1:1:1 randomization to either 32 °C (n = 52), 33 °C (n = 49) or 34 °C (n = 49), via endovascular cooling devices during a 24-h period in comatose survivors of witnessed OHCA and initial shockable rhythm. The primary endpoint was the percentage of subjects surviving with good neurologic outcome defined by a modified Rankin Scale (mRS) score of ≤ 3, blindly assessed at 90 days.

resultsAt baseline, different proportions of patients who had received defibrillation administered by a bystander were assigned to groups of 32 °C (13.5%), 33 °C (34.7%) and 34 °C (28.6%; p = 0.03). The percentage of patients with an mRS ≤ 3 at 90 days (primary endpoint) was 65.3, 65.9 and 65.9% in patients assigned to 32, 33 and 34 °C, respectively, non-significant (NS). The multivariate Cox proportional hazards model identified two variables significantly related to the primary outcome: male gender and defibrillation by a bystander. Among the 43 patients who died before 90 days, 28 died following withdrawal of life-sustaining therapy, as follows: 7/16 (43.8%), 10/13 (76.9%) and 11/14 (78.6%) of patients assigned to 32, 33 and 34 °C, respectively (trend test p = 0.04). All levels of cooling were well tolerated.

conclusionsThere were no statistically significant differences in neurological outcomes among the different levels of TTM. However, future research should explore the efficacy of TTM at 32 °C. CLINICAL

trial registrationClinicalTrials.gov unique identifier: NCT02035839 ( http://clinicaltrials.gov ).

Indexed as

AgedComaFemaleHumansHypothermia, InducedMaleMiddle AgedOut-of-Hospital Cardiac ArrestPilot ProjectsProportional Hazards ModelsProspective StudiesSurvival RateTreatment OutcomeBrain injuryCardiac arrestPost-cardiac arrest syndromeResuscitationSudden deathTargeted temperature management

Identifiers

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.