New findings have called into question the recommended clinical practice of augmenting blood pressure early after acute spinal cord injury (SCI).

In a randomized clinical trial, augmenting blood pressure in the days following acute SCI did not improve long-term neurologic outcomes and was associated with an increased risk for serious complications.

“These findings call into question the efficacy and safety of blood pressure augmentation due to higher complications without appreciable differences in neurologic function,” lead author Ruba Sajdeya, MD, PhD, with Duke University School of Medicine, Durham, North Carolina, and co-authors wrote.

The findings were published online on September 18 in JAMA Network Open.

Time to Revisit Guidelines?

The 2013 American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) SCI guideline advised maintaining mean arterial pressure of 85-90 mm Hg for 7 days after SCI. However, this level 3 recommendation was based on low-quality evidence of neurologic improvement and lacked data from a randomized controlled trial, Sajdeya and colleagues wrote.

More recent guidelines from the AANS/CNS recommended maintaining a mean arterial pressure of 75-80 mm Hg for 3-7 days, but this recommendation was also based on very low-quality evidence, they added.

To address this data gap, researchers did a randomized controlled trial between 2017 and 2023 involving 92 patients (mean age, 54 years; 83% men) with acute traumatic SCI at 13 major US trauma centers.

Participants were randomly assigned to augmented (> 85-90 mm Hg) or conventional (65-70 mm Hg) mean arterial blood pressure targets for 7 days or until discharge from the ICU.

The primary endpoints were changes from baseline to 6 months in motor and sensory scores on the American Spinal Injury Association (ASIA) Impairment Scale. Safety endpoints included organ dysfunction and complications.

At 6 months, 15 patients had died, and 38 had completed the ASIA follow-up and were included in the complete-case intent-to-treat analysis.

Among survivors, there were no significant between-group differences in upper (P = .55) or lower (P = .43) extremity motor scores, or total sensory scores (P = .06) at 6 months.

However, safety analyses showed that patients in the augmented blood pressure group experienced higher organ dysfunction scores by day 3 (P = .008) and day 6 (P = .04) of ICU care and spent a longer average time on mechanical ventilation (9.4 days vs 3.8 days; P = .03).

The augmented group also had nearly double the rate of respiratory complications (78% vs 39%; P < .001), including more cases of pneumonia and pulmonary edema.

There were no differences between groups in pain outcomes, performance in activities of daily living and mobility, satisfaction with the quality of life, cardiovascular functioning, and serious adverse events at 6 months. Mortality rates were similar between the two groups.

Practice-Changing or Hypothesis-Generating?

The researchers cautioned that the sample size was lower than planned, largely due to a lack of enrollment during the COVID-19 pandemic, which may have underpowered the study. In addition, roughly one third of participants were lost to follow-up, in part due to challenges imposed by the pandemic.

Also, because spontaneous blood pressure was not intentionally lowered, average mean arterial pressure values in the conventional group were > 80 mm Hg, which could have contributed to the lack of effect between the two groups from a perfusion standpoint, adding to the uncertainty regarding differences between spontaneous and vasopressor-induced blood pressure targets, the researchers noted.

Given these limitations, they said their findings are “hypothesis-raising regarding optimal hemodynamic management.”

“Further research from adequately powered studies is needed to corroborate the efficacy and safety of mean arterial pressure goals in patients with SCI, identify patient groups who may be more tolerant or benefit from mean arterial pressure augmentation (eg, patients with decompression), determine potential harm mechanisms to guide precision medicine approaches, and ensure the compatibility of treatment protocols with evolving evidence and practical feasibility,” they concluded.

The authors of an invited commentary in JAMA Network Open said the study represents a “meaningful” contribution to the acute SCI literature.

The study results caution “against routine aggressive mean arterial pressure augmentation greater than 85-90 mm Hg given the associated risks without clear neurologic benefit,” wrote Seth Tigchelaar, MD, PhD, and Allan Levi, MD, PhD, with the University of Miami Miller School of Medicine, Miami.

“Clinicians should interpret these findings carefully, recognizing both the study’s limitations and its critical implications for clinical practice. Moving forward, refining guidelines based on rigorous, adequately powered trials remains imperative for optimizing acute SCI management,” they concluded.

The study was supported by a grant from the US Department of Defense Congressionally Directed Medical Research Program. A full list of author disclosures is available with the original article. Tigchelaar and Levi reported having no disclosures.