The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKasr El Aini Hospital

About this trial

The aim of this study is to estimate the effect of discontinuation of RAS inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Both sexes

ASA 2-3

Chronic hypertensive patients (> 3 months before surgery) controlled on ACEIs or ARBs or combination therapy containing one of the RAS inhibitors.

Disqualifiers

Patient refusal.

Recent myocardial infarction (within 3 months).

Any condition, which in the opinion of the treating clinician, would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.

Emergency surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACE-I and/or ARB antihypertensive treatment

    Drug

    When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: stop RASExperimental treatment 1 intervention
Group B: continue RASActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The primary outcome is the incidence of myocardial injury 48 hours after surgery

defined as: (Troponin-I If the baseline is \<0.05 And increase by 0.015 is considered positive If the baseline is higher than 0.05, an increase by 0.005 is considered positive

Time frame
48 hours

Secondary outcomes

1

Highest level of Troponin-I measured within 48 hours of surgery.

Highest level of Troponin-T measured within 48 hours of surgery.

Time frame
48 hours
2

Incidence of perioperative hypotension

Incidence of perioperative hypotension (MAP\<20% of baseline measure recorded night before surgery) until 48 hours after surgery.

Time frame
48 hours
3

Incidence of severe hypotension

Incidence of severe hypotension (MAP \< 60 mmHg requiring any vasopressor) until 48 hours after surgery.

Time frame
48 hours
4

Incidence of perioperative severe hypertension

Incidence of perioperative severe hypertension (BP\>180/100mmHg) until 48 hours after surgery.

Time frame
48 hours

Other outcomes

Sponsors and contacts

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