Publication:
The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial

Simple item page
dc.contributor.authorMa, Lu
dc.contributor.authorHu, Xin
dc.contributor.authorSong, Lili
dc.contributor.authorChen, Xiaoying
dc.contributor.authorOuyang, Menglu
dc.contributor.authorBillot, Laurent
dc.contributor.authorLi, Qiang
dc.contributor.authorMalavera, Alejandra
dc.contributor.authorLi, Xi
dc.contributor.authorMunoz Venturelli, Paula
dc.contributor.authorDe Silva, Asita
dc.contributor.authorHuy Thang, Nguyen
dc.contributor.authorWahab, Kolawole
dc.contributor.authorPandian, Jeyaraj
dc.contributor.authorWasay, Mohammad
dc.contributor.authorPontes, Octavio
dc.contributor.authorAbanto, Carlos
dc.contributor.authorArauz, Antonio
dc.contributor.authorShi, Haiping
dc.contributor.authorTang, Guanghai
dc.contributor.authorZhu, Sheng
dc.contributor.authorShe, Xiaochun
dc.contributor.authorLiu, Leibo
dc.contributor.authorSakamoto, Yuki
dc.contributor.authorYou, Shoujiang
dc.contributor.authorHan, Qiao
dc.contributor.authorCrutzen, Bernard
dc.contributor.authorCheung, Emily
dc.contributor.authorLi, Yunke
dc.contributor.authorWang, Xia
dc.contributor.authorChen, Chen
dc.contributor.authorLiu, Feifeng
dc.contributor.authorZhao, Yang
dc.contributor.authorLi, Hao
dc.contributor.authorLiu, Yi
dc.contributor.authorJiang, Yan
dc.contributor.authorChen, Lei
dc.contributor.authorWu, Bo
dc.contributor.authorLiu, Ming
dc.contributor.authorXu, Jianguo
dc.contributor.authorINTERACT3 Investigators
dc.date.accessioned2024-04-02T16:22:52Z
dc.date.available2024-04-02T16:22:52Z
dc.date.issued2023
dc.descriptionYou, Chao; Anderson, Craig
dc.description.abstractBackground: Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage. Methods: We performed a pragmatic, international, multicentre, blinded endpoint, stepped wedge cluster randomised controlled trial at hospitals in nine low-income and middle-income countries (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Viet Nam) and one high-income country (Chile). Hospitals were eligible if they had no or inconsistent relevant, disease-specific protocols, and were willing to implement the care bundle to consecutive patients (aged ≥18 years) with imaging-confirmed spontaneous intracerebral haemorrhage presenting within 6 h of the onset of symptoms, had a local champion, and could provide the required study data. Hospitals were centrally randomly allocated using permuted blocks to three sequences of implementation, stratified by country and the projected number of patients to be recruited over the 12 months of the study period. These sequences had four periods that dictated the order in which the hospitals were to switch from the control usual care procedure to the intervention implementation of the care bundle procedure to different clusters of patients in a stepped manner. To avoid contamination, details of the intervention, sequence, and allocation periods were concealed from sites until they had completed the usual care control periods. The care bundle protocol included the early intensive lowering of systolic blood pressure (target <140 mm Hg), strict glucose control (target 6·1-7·8 mmol/L in those without diabetes and 7·8-10·0 mmol/L in those with diabetes), antipyrexia treatment (target body temperature ≤37·5°C), and rapid reversal of warfarin-related anticoagulation (target international normalised ratio <1·5) within 1 h of treatment, in patients where these variables were abnormal. Analyses were performed according to a modified intention-to-treat population with available outcome data (ie, excluding sites that withdrew during the study). The primary outcome was functional recovery, measured with the modified Rankin scale (mRS; range 0 [no symptoms] to 6 [death]) at 6 months by masked research staff, analysed using proportional ordinal logistic regression to assess the distribution in scores on the mRS, with adjustments for cluster (hospital site), group assignment of cluster per period, and time (6-month periods from Dec 12, 2017). This trial is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787) and is completed. Findings: Between May 27, 2017, and July 8, 2021, 206 hospitals were assessed for eligibility, of which 144 hospitals in ten countries agreed to join and were randomly assigned in the trial, but 22 hospitals withdrew before starting to enrol patients and another hospital was withdrawn and their data on enrolled patients was deleted because regulatory approval was not obtained. Between Dec 12, 2017, and Dec 31, 2021, 10 857 patients were screened but 3821 were excluded. Overall, the modified intention-to-treat population included 7036 patients enrolled at 121 hospitals, with 3221 assigned to the care bundle group and 3815 to the usual care group, with primary outcome data available in 2892 patients in the care bundle group and 3363 patients in the usual care group. The likelihood of a poor functional outcome was lower in the care bundle group (common odds ratio 0·86; 95% CI 0·76-0·97; p=0·015). The favourable shift in mRS scores in the care bundle group was generally consistent across a range of sensitivity analyses that included additional adjustments for country and patient variables (0·84; 0·73-0·97; p=0·017), and with different approaches to the use of multiple imputations for missing data. Patients in the care bundle group had fewer serious adverse events than those in the usual care group (16·0% vs 20·1%; p=0·0098). Interpretation: Implementation of a care bundle protocol for intensive blood pressure lowering and other management algorithms for physiological control within several hours of the onset of symptoms resulted in improved functional outcome for patients with acute intracerebral haemorrhage. Hospitals should incorporate this approach into clinical practice as part of active management for this serious condition. Funding: Joint Global Health Trials scheme from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, and the Medical Research Council and Wellcome Trust; West China Hospital; the National Health and Medical Research Council of Australia; Sichuan Credit Pharmaceutic and Takeda China.
dc.description.versionPublicada
dc.identifier.citationMa L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Muñoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1
dc.identifier.doihttps://doi.org/10.1016/S0140-6736(23)00806-1
dc.identifier.urihttps://hdl.handle.net/11447/8581
dc.language.isoen
dc.subjectAnticoagulants / therapeutic use
dc.subjectAdolescent
dc.subjectAdult
dc.subjectBlood Pressure
dc.subjectCerebral Hemorrhage / drug therapy
dc.subjectCritical Care
dc.subjectHumans
dc.subjectHypotension
dc.subjectPatient Care Bundles
dc.subjectTreatment Outcome
dc.titleThe third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial
dc.typeArticle
dcterms.accessRightsAcceso Abierto
dcterms.sourceLancet
dspace.entity.typePublication
relation.isAuthorOfPublication77bec604-0a16-4d85-aaee-734c326e253a
relation.isAuthorOfPublication.latestForDiscovery77bec604-0a16-4d85-aaee-734c326e253a

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
3. The third Intensive Care.pdf
Size:
787.15 KB
Format:
Adobe Portable Document Format
Description:
Texto Completo
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
347 B
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

Artículos Medicina y Ciencias de la Salud

Implementado por OpenGeek Services