Could implementing a goal-directed care bundle for lowering blood pressure improve outcomes for patients with intracerebral hemorrhage?

In a recent article published in the Lancet, researchers performed a multicentre, randomized controlled trial (RCT) at hospitals in ten countries, of which nine were low- and middle-income countries (LMICs) and one was a high-income country, Chile.

The LMICs were Brazil, India, China, Mexico, Pakistan, Nigeria, Peru, VietNam, and Sri Lanka.

Study: The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Image Credit: PuwadolJaturawutthichai/Shutterstock.comStudy: The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Image Credit: PuwadolJaturawutthichai/Shutterstock.com

Background

Hypertension, unhealthy diets, e.g., a high salt intake, and many similar risk factors augment the possibility of intracerebral hemorrhage.

Elevated systolic blood pressure (BP) is expected after the onset of intracerebral hemorrhage and is strongly associated with a poor outcome; thus, its early control, i.e., bringing it down to a target of 140 mm Hg or less, appears to be the most promising treatment for acute intracerebral hemorrhage.

Through an intensive screening of published literature, researchers identified three previous trials assessing the effectiveness of a combination of treatments for blood pressure lowering on clinical outcomes of acute intracerebral hemorrhage.

Intracerebral hemorrhage is a type of stroke that is untreatable and accounts for ~20% of the 20 million stroke cases occurring worldwide every year, mostly in LMICs.

 None of these trials fetched adequate evidence that implementing an intensive care bundle could effectively combat acute intracerebral hemorrhage.

About the study

In the present study, researchers designed the Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3) to investigate whether implementing a care bundle in a hospital setting could improve outcomes for patients with intracerebral hemorrhage.

This care bundle protocol targeted normalizing the following physiological variables in patients:

i) lowering systolic BP to 140 mm Hg or less;

ii) lowering glucose levels to 6.1–7.8 mmol/L in nondiabetic and 7.8–10 mmol/L in diabetic patients;

iii) treating pyrexia, i.e., maintaining body temperature ≤37.5°C; and

iv) quick reversion of warfarin-associated anticoagulation to attain a normalized ratio of <1.5 in one hour.

The researchers used a modified Rankin Scale (mRS) to measure improvement in functional outcomes six months post-treatment with the care bundle protocol vis-a-vis usual care. Scores between zero to one on the mRS indicate a favorable outcome, i.e., no disability; between two to five indicate increasing disability; and six indicate death.

Time-varying trends in patient characteristics could not explain these results, encompassing favorable effects on health-related quality of life and survival.

All included hospitals followed disease-specific care protocols and were inclined to implement the care bundle for imaging-confirmed spontaneous intracerebral hemorrhage patients aged ≥18.

These patients presented within six hours of symptom onset, had a local guardian, and consented to give the required study data.

The team randomly allocated three implementation sequences, each with four periods, to all participating hospitals, stratified by country and the estimated number of intracerebral hemorrhage patients it would admit during the study period of one year.

The protocol dictated how the hospitals switched from the usual care to care bundle procedure among different patient clusters following a wedged, stepwise fashion.

The trial had a hybrid discovery–implementation design, in which the team prospectively followed up with all patient clusters to establish their outcome.

The team performed all analyses for a modified intention-to-treat population for whom functional outcome data were available.

It helped them assess the distribution in mRS scores, with adjustments for a cluster, e.g., hospital site, time using a proportional ordinal logistic regression model. It presented the standard odds of worse functional outcomes for the care bundle group than the usual care group.

For instance, the team estimated the standard odds of worse neurological deterioration for the care bundle group compared with the usual care group. National Institutes of Health Stroke Scale (NIHSS) scores ranged between zero and 42, where higher scores indicated more severe neurological deficits.

Likewise, combined scores for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression provided an overall health utility score assessed via EuroQoL Group 5-Dimension (EQ-5D-3L) questionnaire.

Results

The modified intention-to-treat population comprised 7,036  acute intracerebral hemorrhage patients from 121 hospitals with a mean age of 62 years; also, 2,533 (36%) were female, and 6,350 (90.3%) were of Chinese origin.

The team allocated 3,221 and 3,815 patients to the care bundle and the usual care groups, respectively. They had primary outcome data for 2,892 and 3,363 patients in the care bundle and usual care groups, respectively.

The care bundle group individuals had better mRS scores than usual care group people, with a common odds ratio (OR) of 0.86 for mean effect across all mRSs violated in the proportional odds assumption test.

In the care bundle group, favorable shifts in mRS scores remained unperturbed even after replacing missing data using prespecified imputation methods, except for an mRS score of six.

These shifts remained significant even after adjustment for patient characteristics, country, and using varying time trends. Furthermore, the care bundle group patients had fewer serious adverse events than the usual care group patients (16% vs. 20·1%).

Conclusions

Previous trials fetched mixed results concerning the effects of blood pressure-lowering therapies in acute intracerebral hemorrhage patients. Perhaps, variable approaches toward treatment and the use of small sample sizes affected the results.

However, in this trial, implementing a simple, targeted care bundle protocol for early intensive management of systolic BP below 140 mm Hg was safe and effectively improved functional outcomes in acute intracerebral hemorrhage patients.

Thus, the authors recommended incorporating it into clinical practice for disease management.

Journal reference:
Neha Mathur

Written by

Neha Mathur

Neha is a digital marketing professional based in Gurugram, India. She has a Master’s degree from the University of Rajasthan with a specialization in Biotechnology in 2008. She has experience in pre-clinical research as part of her research project in The Department of Toxicology at the prestigious Central Drug Research Institute (CDRI), Lucknow, India. She also holds a certification in C++ programming.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Mathur, Neha. (2023, May 30). Could implementing a goal-directed care bundle for lowering blood pressure improve outcomes for patients with intracerebral hemorrhage?. News-Medical. Retrieved on July 24, 2024 from https://www.news-medical.net/news/20230530/Could-implementing-a-goal-directed-care-bundle-for-lowering-blood-pressure-improve-outcomes-for-patients-with-intracerebral-hemorrhage.aspx.

  • MLA

    Mathur, Neha. "Could implementing a goal-directed care bundle for lowering blood pressure improve outcomes for patients with intracerebral hemorrhage?". News-Medical. 24 July 2024. <https://www.news-medical.net/news/20230530/Could-implementing-a-goal-directed-care-bundle-for-lowering-blood-pressure-improve-outcomes-for-patients-with-intracerebral-hemorrhage.aspx>.

  • Chicago

    Mathur, Neha. "Could implementing a goal-directed care bundle for lowering blood pressure improve outcomes for patients with intracerebral hemorrhage?". News-Medical. https://www.news-medical.net/news/20230530/Could-implementing-a-goal-directed-care-bundle-for-lowering-blood-pressure-improve-outcomes-for-patients-with-intracerebral-hemorrhage.aspx. (accessed July 24, 2024).

  • Harvard

    Mathur, Neha. 2023. Could implementing a goal-directed care bundle for lowering blood pressure improve outcomes for patients with intracerebral hemorrhage?. News-Medical, viewed 24 July 2024, https://www.news-medical.net/news/20230530/Could-implementing-a-goal-directed-care-bundle-for-lowering-blood-pressure-improve-outcomes-for-patients-with-intracerebral-hemorrhage.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Can nuts boost weight loss and blood sugar control on a calorie-restricted diet?