Document Detail


A trial of intracranial-pressure monitoring in traumatic brain injury.
MedLine Citation:
PMID:  23234472     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Intracranial-pressure monitoring is considered the standard of care for severe traumatic brain injury and is used frequently, but the efficacy of treatment based on monitoring in improving the outcome has not been rigorously assessed.
METHODS: We conducted a multicenter, controlled trial in which 324 patients 13 years of age or older who had severe traumatic brain injury and were being treated in intensive care units (ICUs) in Bolivia or Ecuador were randomly assigned to one of two specific protocols: guidelines-based management in which a protocol for monitoring intraparenchymal intracranial pressure was used (pressure-monitoring group) or a protocol in which treatment was based on imaging and clinical examination (imaging-clinical examination group). The primary outcome was a composite of survival time, impaired consciousness, and functional status at 3 months and 6 months and neuropsychological status at 6 months; neuropsychological status was assessed by an examiner who was unaware of protocol assignment. This composite measure was based on performance across 21 measures of functional and cognitive status and calculated as a percentile (with 0 indicating the worst performance, and 100 the best performance).
RESULTS: There was no significant between-group difference in the primary outcome, a composite measure based on percentile performance across 21 measures of functional and cognitive status (score, 56 in the pressure-monitoring group vs. 53 in the imaging-clinical examination group; P=0.49). Six-month mortality was 39% in the pressure-monitoring group and 41% in the imaging-clinical examination group (P=0.60). The median length of stay in the ICU was similar in the two groups (12 days in the pressure-monitoring group and 9 days in the imaging-clinical examination group; P=0.25), although the number of days of brain-specific treatments (e.g., administration of hyperosmolar fluids and the use of hyperventilation) in the ICU was higher in the imaging-clinical examination group than in the pressure-monitoring group (4.8 vs. 3.4, P=0.002). The distribution of serious adverse events was similar in the two groups.
CONCLUSIONS: For patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at 20 mm Hg or less was not shown to be superior to care based on imaging and clinical examination. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01068522.).
Authors:
Randall M Chesnut; Nancy Temkin; Nancy Carney; Sureyya Dikmen; Carlos Rondina; Walter Videtta; Gustavo Petroni; Silvia Lujan; Jim Pridgeon; Jason Barber; Joan Machamer; Kelley Chaddock; Juanita M Celix; Marianna Cherner; Terence Hendrix;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-12-12
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-27     Completed Date:  2013-01-07     Revised Date:  2014-06-11    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2471-81     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01068522
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MeSH Terms
Descriptor/Qualifier:
Adult
Brain / physiopathology,  radiography*
Brain Injuries / complications,  mortality,  physiopathology*
Female
Humans
Intracranial Hypertension / diagnosis*,  etiology
Intracranial Pressure*
Kaplan-Meier Estimate
Length of Stay
Male
Monitoring, Physiologic* / instrumentation,  methods
Neurologic Examination*
Survival Rate
Tomography, X-Ray Computed
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
R01 NS058302/NS/NINDS NIH HHS; R01 NS080648/NS/NINDS NIH HHS; R0INS058302//PHS HHS
Investigator
Investigator/Affiliation:
R M Chesnut / ; C Rondina / ; W Videtta / ; N Temkin / ; S Dikmen / ; N Carney / ; G Petroni / ; S Lujan / ; J Pridgeon / ; J Barber / ; J Machamer / ; K Chaddock / ; J Celix / ; M Cherner / ; T Hendrix / ; V S Alanis Mirones / ; G La Fuente Zerain / ; A Lavadenz Cuentas / ; R Merida Maldonado / ; F Sandi Lora / ; E M Jibaja Vega / ; Carlos Alcala / ; Diego Barahona / ; Erick Garcia / ; Marcos Mello Moreira / ; Juan Pablo Merida / ; Diego Monzon / ; Maria Isabel Navajas Krutzfeldt / ; Vianka Valle / ; Saul Zavala / ; Reina Alvarado / ; Alejandra Anziano / ; Rafael Camargo / ; Rita Isabel Cervantes Zambrana / ; Maria Luisa Chavez / ; Rosmery Gross / ; Luiz Guilherme Calderom / ; Fernando Justiniano / ; Maria Julia Maida / ; Viviana Nathaly Medranda Pisco / ; Arturo Flor Morquera / ; Carlos Eduardo Rocha / ; Jesusa Torres / ; Katty Alexandra Trelles Vasquez / ; Maria del Carmen Valverde / ; Elisa Vilca / ; Veronica Vinzia / ; A L Eiras Falcao / ; C Puppo / ; R Romero Figueroa /
Comments/Corrections
Comment In:
World Neurosurg. 2013 May-Jun;79(5-6):600-1   [PMID:  23531729 ]
N Engl J Med. 2013 May 2;368(18):1748   [PMID:  23635058 ]
N Engl J Med. 2013 May 2;368(18):1749-50   [PMID:  23635061 ]
N Engl J Med. 2013 May 2;368(18):1750   [PMID:  23635062 ]
N Engl J Med. 2013 May 2;368(18):1749   [PMID:  23635060 ]
N Engl J Med. 2013 May 2;368(18):1748-9   [PMID:  23635059 ]
N Engl J Med. 2013 May 2;368(18):1750-1   [PMID:  23635063 ]
Anaesthesist. 2013 Jul;62(7):562-7   [PMID:  23812273 ]
N Engl J Med. 2013 May 2;368(18):1751-2   [PMID:  23635057 ]
World Neurosurg. 2013 May-Jun;79(5-6):599-600   [PMID:  23528795 ]
World Neurosurg. 2013 May-Jun;79(5-6):602-4   [PMID:  23531728 ]
N Engl J Med. 2012 Dec 27;367(26):2539-41   [PMID:  23234471 ]
Erratum In:
N Engl J Med. 2013 Dec 19;369(25):2465

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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