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

التفاصيل البيبلوغرافية
العنوان: Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial.
المؤلفون: Nordness MF; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Section of Surgical Sciences, Division of Acute Care Surgery, Department of Surgery, VUMC, 1211 21st Avenue South, Medical Arts Building, Suite 404, Nashville, TN, 37212, USA., Maiga AW; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Section of Surgical Sciences, Division of Acute Care Surgery, Department of Surgery, VUMC, 1211 21st Avenue South, Medical Arts Building, Suite 404, Nashville, TN, 37212, USA.; Surgical Services at the Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN, 37212, USA., Wilson LD; Department of Hearing & Speech Sciences, VUMC, 1215 21st Avenue South, Medical Center East, Room 8310, Nashville, TN, 37232, USA.; College of Health Sciences & Communication Sciences and Disorders at the University of Tulsa, 800 S Tucker Drive, Tulsa, OK, 74104, USA., Koyama T; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Department of Biostatistics, VUMC, Room 11133B, 2525 West End Avenue, Nashville, TN, 37203, USA., Rivera EL; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Section of Surgical Sciences, Division of Acute Care Surgery, Department of Surgery, VUMC, 1211 21st Avenue South, Medical Arts Building, Suite 404, Nashville, TN, 37212, USA., Rakhit S; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Section of Surgical Sciences, Division of Acute Care Surgery, Department of Surgery, VUMC, 1211 21st Avenue South, Medical Arts Building, Suite 404, Nashville, TN, 37212, USA., de Riesthal M; Department of Hearing & Speech Sciences, VUMC, 1215 21st Avenue South, Medical Center East, Room 8310, Nashville, TN, 37232, USA., Motuzas CL; Department of Radiology and Radiological Sciences, VUMC, Medical Center North, 1161 21st Avenue South, Nashville, TN, 37232, USA., Cook MR; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Meharry Medical College, 1005 Dr. DB Todd Jr Blvd, Nashville, TN, 37208, USA., Gupta DK; Division of Cardiovascular Medicine, Vanderbilt Translational and Clinical Cardiovascular Research Center, VUMC, 2525 West End, Suite 300-A, Nashville, TN, 37203, USA., Jackson JC; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA., Williams Roberson S; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA., Meurer WJ; University of Michigan Emergency Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA., Lewis RJ; Department of Emergency Medicine, Harbor-University of California Los Angeles, 1000 W Carson St, Torrance, CA, 90502, USA., Manley GT; Department of Neurological Surgery, University of California San Francisco, 505 Parnassus Ave, Room M779, Box 0112, San Francisco, CA, 94143, USA., Pandharipande PP; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center (VUMC), Suite 450, 4th Floor, 2525 West End Avenue, Nashville, TN, 37203, USA.; Center for Health Services Research, Institute for Medicine and Public Health, VUMC, 2525 West End Avenue, Nashville, TN, 37203, USA.; Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology, VUMC, 1211 Medical Center Drive, Nashville, TN, 37232, USA.; Geriatric Research, Education and Clinical Center (GRECC), Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN, 37212, USA., Patel MB; Critical 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.; Section of Surgical Sciences, Division of Acute Care Surgery, Department of Surgery, VUMC, 1211 21st Avenue South, Medical Arts Building, Suite 404, Nashville, TN, 37212, USA. mayur.b.patel@vumc.org.; Department of Hearing & Speech Sciences, VUMC, 1215 21st Avenue South, Medical Center East, Room 8310, Nashville, TN, 37232, USA. mayur.b.patel@vumc.org.; Center for Health Services Research, Institute for Medicine and Public Health, VUMC, 2525 West End Avenue, Nashville, TN, 37203, USA. mayur.b.patel@vumc.org.; Vanderbilt Brain Institute, VUMC, 7203 Medical Research Building III, 465 21st Avenue South, Nashville, TN, USA. mayur.b.patel@vumc.org.; Geriatric Research, Education and Clinical Center (GRECC), Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN, 37212, USA. mayur.b.patel@vumc.org.; Surgical Services at the Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN, 37212, USA. mayur.b.patel@vumc.org.
المصدر: Critical care (London, England) [Crit Care] 2023 Jun 09; Vol. 27 (1), pp. 228. Date of Electronic Publication: 2023 Jun 09.
نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase II; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Ltd Country of Publication: England NLM ID: 9801902 Publication Model: Electronic Cited Medium: Internet ISSN: 1466-609X (Electronic) Linking ISSN: 13648535 NLM ISO Abbreviation: Crit Care Subsets: MEDLINE
أسماء مطبوعة: Publication: London, UK : BioMed Central Ltd
Original Publication: London : Current Science Ltd, c1997-
مواضيع طبية MeSH: Propranolol*/pharmacology , Propranolol*/therapeutic use , Brain Injuries, Traumatic*/complications , Brain Injuries, Traumatic*/drug therapy, Humans ; Clonidine/pharmacology ; Clonidine/therapeutic use ; Pilot Projects ; Treatment Outcome ; Adrenergic Agents
مستخلص: Objective: To evaluate the safety, feasibility, and efficacy of combined adrenergic blockade with propranolol and clonidine in patients with severe traumatic brain injury (TBI).
Background: Administration of adrenergic blockade after severe TBI is common. To date, no prospective trial has rigorously evaluated this common therapy for benefit.
Methods: This 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.
Results: Dose 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.
Conclusion: Despite 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.
(© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
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معلومات مُعتمدة: R01HL111111 United States HL NHLBI NIH HHS; R01 GM120484 United States GM NIGMS NIH HHS; T32 GM135094 United States GM NIGMS NIH HHS; R01AG058639 United States AG NIA NIH HHS; I01 RX002992 United States RX RRD VA; K23 GM150110 United States GM NIGMS NIH HHS; F32AG062045 United States AG NIA NIH HHS; R25 NS088248 United States NS NINDS NIH HHS; T32GM135094 United States GM NIGMS NIH HHS; 1K23GM150110 United States GM NIGMS NIH HHS; R01GM120484 United States GM NIGMS NIH HHS
فهرسة مساهمة: Keywords: Adrenergic blockade; Critical care; Paroxysmal sympathetic hyperactivity; Traumatic brain injury
سلسلة جزيئية: ClinicalTrials.gov NCT01322048
المشرفين على المادة: 9Y8NXQ24VQ (Propranolol)
MN3L5RMN02 (Clonidine)
0 (Adrenergic Agents)
تواريخ الأحداث: Date Created: 20230609 Date Completed: 20230612 Latest Revision: 20240601
رمز التحديث: 20240601
مُعرف محوري في PubMed: PMC10251526
DOI: 10.1186/s13054-023-04479-6
PMID: 37296432
قاعدة البيانات: MEDLINE
الوصف
تدمد:1466-609X
DOI:10.1186/s13054-023-04479-6