Evidence map›Paper›PMID 35978368›Full record

ArticleTrials2022

The effect of continuing versus withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers on mortality and major adverse cardiovascular events in hypertensive patients undergoing elective non-cardiac surgery: study protocol for a multi-centric open-label randomised controlled trial.

Satyajeet Misra, Satyen Parida, Raj Sahajanandan, Bikram Kishore Behera, Muthapillai Senthilnathan, Ramamani Mariappan, Tony Thomson Chandy, ACE investigators

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Satyajeet MisraAIIMS Bhubaneswar, Bhubaneswar, Odisha, 751019, India. misrasatyajeet@gmail.com.ORCID http://orcid.org/0000-0001-8097-0338
Satyen ParidaJIPMER Puducherry, Puducherry, India.
Raj SahajanandanCMC Vellore, Vellore, India.
Bikram Kishore BeheraAIIMS Bhubaneswar, Bhubaneswar, Odisha, 751019, India.
Muthapillai SenthilnathanJIPMER Puducherry, Puducherry, India.
Ramamani MariappanCMC Vellore, Vellore, India.
Tony Thomson ChandyCMC Vellore, Vellore, India.
ACE investigators
All India Institute of Medical Sciences Bhubaneswar · INJawaharlal Institute of Post Graduate Medical Education and Research · IN

Funding

Indian Council of Medical Research 2020-4671
6 · The paper itself

Abstract

backgroundAngiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) are commonly prescribed to patients with hypertension. These drugs are cardioprotective in addition to their blood pressure-lowering effects. However, it is debatable whether hypertensive patients who present for non-cardiac surgery should continue or discontinue these drugs preoperatively. Continuing the drugs entails the risk of perioperative refractory hypotension and/or angioneurotic oedema, while discontinuing the drugs entails the risk of rebound hypertension and myocardial ischaemia. The aim of this study is to evaluate the effect of continuation vs withholding of ACEIs/ARBs on mortality and other major outcomes in hypertensive patients undergoing elective non-cardiac surgery.

methodsThe continuing vs withholding of ACEIs/ARBs in patients undergoing non-cardiac surgery is a prospective, multi-centric, open-label randomised controlled trial. Two thousand one hundred hypertensive patients receiving ACEIs/ARBs and planned for elective non-cardiac surgery will be enrolled. They will be randomised to either continue the ACEIs/ARBs including on the day of surgery (group A) or to withhold it 24-36 h before surgery (group B). The primary endpoint will be the difference in the composite outcome of all-cause in-hospital/30-day mortality and major adverse cardiovascular and non-cardiovascular events. Secondary endpoints will be to evaluate the differences in perioperative hypotension, angioneurotic oedema, myocardial injury, ICU and hospital stay. The impact of the continuation vs withholding of the ACEIs/ARBs on the incidence of case cancellation will also be studied. DISCUSSION: The results of this trial should provide sufficient evidence on whether to continue or withhold ACEIs/ARBs before major non-cardiac surgery.

trial registrationClinical Trials Registry of India CTRI/2021/01/030199. Registered on 4 January 2021.

Indexed as

AngioedemaHypertensionHypotensionAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsHumansProspective StudiesRandomized Controlled Trials as TopicAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsACE inhibitorsAcute kidney injuryAngioedemaARBComplicationsMortalityOutcomes

Identifiers

PMID35978368
PMCPMC9386985
OpenAlexW4292264018

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.