Evidence map›Paper›PMID 37296432›Full record

Trial reportCritical care (London, England)2023

Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial.

Mina F Nordness, Amelia W Maiga, Laura D Wilson, Tatsuki Koyama, Erika L Rivera, Shayan Rakhit, Michael de Riesthal, Cari L Motuzas, Madison R Cook, Deepak K Gupta and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Critical care (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01322048 (DASH After TBI Study), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
7.3field-weighted citation impact, top 2% 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.

NCT01322048 phase2completednot on this map

DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Severe Traumatic Brain Injury, A Pilot Randomized Clinical Trial Using Propranolol and Clonidine

TypeinterventionalSponsorVanderbilt UniversityRan2011 to 2016Enrolled48ConditionsBrain Injuries, Craniocerebral Trauma, Trauma, Nervous System, Traumatic Brain InjuryArmsIV Propranolol and Per Tube Clonidine, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Article
  3. Neuropharmacology in pediatric traumatic brain injury.Journal of pediatric rehabilitation medicine · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. 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

17 authors at 9 institutions in 2 countries.

Mina F NordnessCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Amelia W MaigaCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Laura D WilsonDepartment of Hearing & Speech Sciences, VUMC, 1215 21st Avenue South, Medical Center East, Room 8310, Nashville, TN, 37232, USA.
Tatsuki KoyamaCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Erika L RiveraCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Shayan RakhitCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Michael de RiesthalDepartment of Hearing & Speech Sciences, VUMC, 1215 21st Avenue South, Medical Center East, Room 8310, Nashville, TN, 37232, USA.
Cari L MotuzasDepartment of Radiology and Radiological Sciences, VUMC, Medical Center North, 1161 21st Avenue South, Nashville, TN, 37232, USA.
Madison R CookCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Deepak K GuptaDivision of Cardiovascular Medicine, Vanderbilt Translational and Clinical Cardiovascular Research Center, VUMC, 2525 West End, Suite 300-A, Nashville, TN, 37203, USA.
James C JacksonCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Shawniqua Williams RobersonCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
William J MeurerUniversity of Michigan Emergency Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
Roger J LewisDepartment of Emergency Medicine, Harbor-University of California Los Angeles, 1000 W Carson St, Torrance, CA, 90502, USA.
Geoffrey T ManleyDepartment of Neurological Surgery, University of California San Francisco, 505 Parnassus Ave, Room M779, Box 0112, San Francisco, CA, 94143, USA.
Pratik P PandharipandeCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.
Mayur B PatelCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA. mayur.b.patel@vumc.org.
Vanderbilt University Medical Center · USGeriatric Research Education and Clinical Center · USMeharry Medical College · USMichigan Medicine · USNashville VA Medical Center · USUCLA Medical Center · USUniversity of California, San Francisco · USUniversity of Tulsa · USWest End Hospital · GH

Funding

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
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
Enhancing Scientific Inquiry in Clinical Neurosciences Through Methodology TrainiR25NS088248 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI COFFEY, CHRISTOPHER S., GUTMANN, LAURIE · 2014 to 2018
$2.3M
Interdisciplinary Training in Injury and Critical IllnessT32GM135094 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PATEL, MAYUR B · 2021 to 2025
$967k
Improving Prognostication for Traumatic Brain InjuryK23GM150110 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Amelia Maiga · 2023 to 2026
$695k
ADRD after Injury in the Elderly Study: Alzheimer's Disease or Related Dementia after Injury in the Elderly StudyF32AG062045 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI NORDNESS, MINA F · 2019 to 2021
$149k
Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Pilot Randomized Clinical Trial (RETURN-III Pilot RCT)I01RX002992 · VA · VETERANS HEALTH ADMINISTRATION · PI ELY, E WESLEY, PATEL, MAYUR B · 2020 to 2025
–
NHLBI NIH HHS R01HL111111NIA NIH HHS F32AG062045NIA NIH HHS R01 AG058639NIA NIH HHS R01AG058639NIGMS NIH HHS 1K23GM150110NIGMS NIH HHS K23 GM150110NIGMS NIH HHS R01 GM120484NIGMS NIH HHS R01GM120484NIGMS NIH HHS T32 GM135094NIGMS NIH HHS T32GM135094NINDS NIH HHS R25 NS088248RRD VA I01 RX002992
6 · The paper itself

Abstract

objectiveTo evaluate the safety, feasibility, and efficacy of combined adrenergic blockade with propranolol and clonidine in patients with severe traumatic brain injury (TBI).

backgroundAdministration of adrenergic blockade after severe TBI is common. To date, no prospective trial has rigorously evaluated this common therapy for benefit.

methodsThis phase II, single-center, double-blinded, pilot randomized placebo-controlled trial included patients aged 16-64 years with severe TBI (intracranial hemorrhage and Glasgow Coma Scale score ≤ 8) within 24 h of ICU admission. Patients received propranolol and clonidine or double placebo for 7 days. The primary outcome was ventilator-free days (VFDs) at 28 days. Secondary outcomes included catecholamine levels, hospital length of stay, mortality, and long-term functional status. A planned futility assessment was performed mid-study.

resultsDose compliance was 99%, blinding was intact, and no open-label agents were used. No treatment patient experienced dysrhythmia, myocardial infarction, or cardiac arrest. The study was stopped for futility after enrolling 47 patients (26 placebo, 21 treatment), per a priori stopping rules. There was no significant difference in VFDs between treatment and control groups [0.3 days, 95% CI (- 5.4, 5.8), p = 1.0]. Other than improvement of features related to sympathetic hyperactivity (mean difference in Clinical Features Scale (CFS) 1.7 points, CI (0.4, 2.9), p = 0.012), there were no between-group differences in the secondary outcomes.

conclusionDespite the safety and feasibility of adrenergic blockade with propranolol and clonidine after severe TBI, the intervention did not alter the VFD outcome. Given the widespread use of these agents in TBI care, a multi-center investigation is warranted to determine whether adrenergic blockade is of therapeutic benefit in patients with severe TBI. Trial Registration Number NCT01322048.

Indexed as

Brain Injuries, TraumaticPropranololAdrenergic AgentsClonidineHumansPilot ProjectsTreatment OutcomeAdrenergic AgentsClonidinePropranololAdrenergic blockadeCritical careParoxysmal sympathetic hyperactivityTraumatic brain injury

Identifiers

PMID37296432
PMCPMC10251526
OpenAlexW4380089355

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.