Evidence map›Paper›PMID 32102644›Full record

Trial reportCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2020

Statistical analysis plan for the Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure trial.

Rameela Chandrasekhar, Christopher G Hughes, Brenda T Pun, Onur M Orun, E Wesley Ely, Pratik P Pandharipande

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC
In one paragraph

Trial report in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01739933 (Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT01739933 phase3completednot on this map

Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis

TypeinterventionalSponsorVanderbilt University Medical CenterRan2013 to 2019Enrolled438ConditionsSepsis, Delirium, Impaired CognitionArmsDexmedetomidine, Propofol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Interventions for preventing intensive care unit delirium in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. 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

6 authors.

Rameela ChandrasekharCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA. rameela.chandrasekhar@vanderbilt.edu.
Christopher G HughesCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA.
Brenda T PunCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA.
Onur M OrunCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA.
E Wesley ElyCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA.
Pratik P PandharipandeCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN, USA.

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
BRAIN-ICU-2 Study: Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction (Dementia) in ICU Survivors, 2nd StudyR01AG058639 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ELY, E WESLEY, JEFFERSON, ANGELA L. · 2019 to 2024
$18.3M
The MIND USA StudyR01AG035117 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ELY, E WESLEY · 2011 to 2016
$7.3M
Supplement to Network for Investigation of Delirium across the U.S (NIDUS)R24AG054259 · NIA · HEBREW REHABILITATION CENTER FOR AGED · PI INOUYE, SHARON K. · 2016 to 2020
$4.3M
Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe SepsisR01HL111111 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PANDHARIPANDE, PRATIK · 2012 to 2017
$3.7M
The INSIGHT-ICU Study: Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms Gleaned after Hospitalization in Trauma-ICU StudyR01GM120484 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PATEL, MAYUR B · 2017 to 2021
$3.0M
Role of Endothelial and Brain Injury in Acute and Long-term Brain DysfunctionR03AG045085 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HUGHES, CHRISTOPHER · 2014 to 2015
$232k
NCATS NIH HHS UL1 TR002243NHLBI NIH HHS R01 HL111111NIA NIH HHS R01 AG035117NIA NIH HHS R01 AG058639NIA NIH HHS R03 AG045085NIA NIH HHS R24 AG054259NIGMS NIH HHS R01 GM120484
6 · The paper itself

Abstract

backgroundThe best sedative medication to reduce delirium, mortality and long term brain dysfunction in mechanically ventilated septic patients is unclear. This multicentre, double-blind, randomised trial investigates the short term and long term effects of dexmedetomidine versus propofol for sedation in mechanically ventilated severely septic patients.

objectivesTo describe the statistical analysis plan for this randomised clinical trial comprehensively and place it in the public domain before unblinding.

methodsTo ensure that analyses are not selectively reported, we developed a comprehensive statistical analysis plan before unblinding. This trial has an enrolment target of 420 severely septic and mechanically ventilated adult patients, randomly assigned to dexmedetomidine or propofol in a 1:1 ratio. Enrolment was completed in January 2019, and the study was estimated to be completed in September 2019. The primary endpoint is days alive without delirium or coma during first 14 study days. Secondary outcomes include 28-day ventilator-free days, 90-day all-cause mortality and cognitive function at 180 days. Time frames all begin on the day of randomisation. All analyses will be conducted on an intention-to-treat basis.

conclusionThis study will compare the effects of two sedatives in mechanically ventilated severely septic patients. In keeping with the guidance on statistical principles for clinical trials, we have developed a comprehensive statistical analysis plan by which we will adhere, as this will avoid bias and support transparency and reproducibility.

trial registrationClinicalTrials.gov (NCT01739933).

Indexed as

AdultCritical IllnessDeliriumDouble-Blind MethodHospital MortalityHumansHypnotics and SedativesIntensive Care UnitsOutcome Assessment, Health CareReproducibility of ResultsRespiration, ArtificialRespiratory InsufficiencySepsisHypnotics and Sedatives

Identifiers

PMID32102644
PMCPMC10692449

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.