Evidence map›Paper›PMID 35246202›Full record

ArticleTrials2022

Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial.

David J Gagnon, Sergey V Ryzhov, Meghan A May, Richard R Riker, Bram Geller, Teresa L May, Sarah Bockian, Joanne T deKay, Ashley Eldridge, Thomas Van der Kloot and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04999592 (Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
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.

NCT04999592 phase2terminatednot on this map

Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT): a Randomized-controlled Trial and Microbiome Assessment

TypeinterventionalSponsorDavid J. GagnonRan2021 to 2024Enrolled53ConditionsOut-Of-Hospital Cardiac Arrest, PneumoniaArmsStandard of care without prophylaxis, Antibiotic prophylaxis
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
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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

20 authors at 4 institutions in 1 country.

David J GagnonDepartment of Pharmacy, Maine Medical Center, Portland, ME, USA. dgagnon@mmc.org.
Sergey V RyzhovMaine Medical Center Research Institute, Scarborough, ME, USA.
Meghan A MayUniversity of New England College of Osteopathic Medicine, Biddeford, ME, USA.
Richard R RikerTufts University School of Medicine, Boston, MA, USA.
Bram GellerTufts University School of Medicine, Boston, MA, USA.
Teresa L MayMaine Medical Center Research Institute, Scarborough, ME, USA.
Sarah BockianMaine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.
Joanne T deKayMaine Medical Center Research Institute, Scarborough, ME, USA.
Ashley EldridgeMaine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.
Thomas Van der KlootDepartment of Critical Care Services, Maine Medical Center, Portland, ME, USA.
Patricia LerwickDepartment of Critical Care Services, Maine Medical Center, Portland, ME, USA.
Christine LordMaine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.
F Lee LucasMaine Medical Center Research Institute, Scarborough, ME, USA.
Patrick MaillouxDepartment of Critical Care Services, Maine Medical Center, Portland, ME, USA.
Barbara McCrumMaine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.
Meghan SearightMaine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.
Joel WirthDepartment of Critical Care Services, Maine Medical Center, Portland, ME, USA.
Jonathan ZuckermanTufts University School of Medicine, Boston, MA, USA.
Douglas SawyerMaine Medical Center Research Institute, Scarborough, ME, USA.
David B SederMaine Medical Center Research Institute, Scarborough, ME, USA.
Maine Medical Center · USMaine Medical Center Research Institute · USTufts University · USUniversity of New England · US

Funding

Understanding Factors Influencing COVID-19 Testing and Vaccination in Immigrant Low-income and Homeless Populations and Testing Targeted InterventionsU54GM115516 · NIGMS · MAINEHEALTH · PI CLIFFORD JAMES ROSEN · 2017 to 2026
$51.6M
Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal EncephalopathyP20GM139745 · NIGMS · MAINEHEALTH · PI David B. Seder · 2021 to 2026
$19.2M
NIGMS NIH HHS P20 GM139745NIGMS NIH HHS U54 GM115516
6 · The paper itself

Abstract

backgroundPneumonia is the most common infection after out-of-hospital cardiac arrest (OHCA) occurring in up to 65% of patients who remain comatose after return of spontaneous circulation. Preventing infection after OHCA may (1) reduce exposure to broad-spectrum antibiotics, (2) prevent hemodynamic derangements due to local and systemic inflammation, and (3) prevent infection-associated morbidity and mortality.

methodsThe ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arrest (PROTECT) trial is a randomized, placebo-controlled, single-center, quadruple-blind (patient, treatment team, research team, outcome assessors), non-commercial, superiority trial to be conducted at Maine Medical Center in Portland, Maine, USA. Ceftriaxone 2 g intravenously every 12 h for 3 days will be compared with matching placebo. The primary efficacy outcome is incidence of early-onset pneumonia occurring < 4 days after mechanical ventilation initiation. Concurrently, T cell-mediated inflammation bacterial resistomes will be examined. Safety outcomes include incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea. The trial will enroll 120 subjects over approximately 3 to 4 years. DISCUSSION: The PROTECT trial is novel in its (1) inclusion of OHCA survivors regardless of initial heart rhythm, (2) use of a low-risk antibiotic available in the USA that has not previously been tested after OHCA, (3) inclusion of anti-inflammatory effects of ceftriaxone as a novel mechanism for improved clinical outcomes, and (4) complete metagenomic assessment of bacterial resistomes pre- and post-ceftriaxone prophylaxis. The long-term goal is to develop a definitive phase III trial powered for mortality or functional outcome.

trial registrationClinicalTrials.gov NCT04999592 . Registered on August 10, 2021.

Indexed as

Out-of-Hospital Cardiac ArrestPneumoniaCeftriaxoneDouble-Blind MethodEquivalence Trials as TopicHumansInflammationRandomized Controlled Trials as TopicTreatment OutcomeCeftriaxoneAntibioticsCardiac arrestCeftriaxoneHypothermiaInflammationMetagenomicsMicrobiomePneumoniaTargeted temperature management

Identifiers

PMID35246202
PMCPMC8895836
OpenAlexW4214835176

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.