Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury - TEMPLE
Abstract
Rationale and objectives: Experiencing lower blood pressure is a common event following high spinal cord injury (SCI). Prevention of low blood pressure and early management in an Intensive Care Unit has saved lives and improved the functional results among survivors of SCI. While it is known that managing blood pressure improves outcomes for patients, the best blood pressure range is not yet known. The objective of this study is to determine if targeted blood pressure manipulation will improve patient outcomes, including neurological function, functional independence, pain levels, and quality of life after SCI. We propose a large study that investigates the efficacy and safety of two different blood pressure levels in patients suffering from acute SCI. In one group, patients will have their mean arterial pressure (MAP) increased and kept at a level equal or greater than 85-90 mm Hg (augmentation group). In the other group, called conventional blood pressure, MAP will be kept in the range of 65-70 mm Hg (conventional group). The blood pressure protocol will be maintained for 7 days after the injury. Patients will be assigned to one of the two groups by chance, like the flip of a coin. The study will be conducted at 5 large trauma centers in the United States and will include approximately 152 patients. Applicability of the research: While there is an acute contusion or bruise with swelling of the spinal cord, there is a window of opportunity to preserve some sections of the spinal cord near the level of injury, before they suffer irreversible damage. Today, it is unknown what blood pressure is optimal to help preserve these sections of the spinal cord at risk of ongoing damage. This study will provide guidance to care providers on how to manage blood pressure in the first week after the injury to achieve the best short- and long-term results. Persons with SCI that will be helped by this study: The results of this research will apply to virtually all patients who present to the hospital after suffering a SCI of the cervical or higher thoracic spine when the function of their muscles is completely compromised below the level of their injury and their sensation is impaired. It will help all these patients, since hemodynamic managements are universally applied in these types of SCI. Potential clinical applications, benefit, and risks: Blood pressure is measured in all patients after SCI and needs to be manipulated in most patients. Since maintenance of adequate blood pressure is so important, this management is part of routine care. There are potential risks associated with blood pressure manipulation, and the use of drugs to increase blood pressure including irregular heart rhythm, cardiac ischemia, or pulmonary edema. These risks might be warranted if blood pressure manipulation leads to improved long-term functioning. Projected Time to Achieve a Person-Related Outcome: The identification of an optimal blood pressure strategy may have great influence on the inpatient complications and subsequent neurological prognosis. While we implement these interventions very early, we believe that the benefits can be sustained and can be best evaluated after 6 months. It is possible that these person-related outcomes can be achieved sooner. Contributions of the proposed research to advancing the field of SCI research, patient care, and quality of life: The proposed project can bring important contributions to the field of SCI research. The study is designed to determine if increasing blood pressure improves patient care, functional results, and quality of life. The study will establish if maintaining blood pressure at certain values after the acute injury is safe and effective in improving patient function in the long term. If the study intervention does not have a clinically meaningful effect on outcome, then these findings would indicate that there is no need to increase blood pressure after acute
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610748
Entities
People
- Miriam Treggiari
Organizations
- Oregon Health & Science University
- United States Army