Comparison of low dose vs high dose nitroglycerine in management of acute pulmonary edema for the reduction of mean arterial pressure.

Materials and Methods:

a) Study Design: Comparative study

b) Study Duration: 18months

c) Sampling technique:

Sample size estimated as 48 in each group, considering the % of MAP goal achieved in low dose group as 22% and high dose group as 57% (ref), and 90 % power, 5% alpha error.

d) Study setting and M****ethod of collection of data:

This is randomized study in patients presenting to Emergency Department, JSS Hospital, Mysuru with hypertensive acute pulmonary edema

Patients will be included in the study after applying inclusion and exclusion criteria. Informed consent will be obtained and filed. Usual patient care will be continued as per standard assessment and management.

Method

·         patient with age>18 years  with features of Hypertensive Acute Pulmonary edema presenting to JSS emergency

·         Block randomization(Block randomization will be done with block of 10 each and the allocation would be done with SNOSE technique)into low dose and high dose nitroglycerine group

·         Low dose group will receive nitroglycerine at 5 mcg/min , blood pressure will be recorded every 5 minutes and nitroglycerine infusion will be titrated accordingly.  Reduction in mean arterial pressure at the end of 1 hour will be assessed.

·         High dose group will receive nitroglycerine at 100mcg/min , blood pressure will be recorded every 5 minutes and nitroglycerine infusion will be titrated accordingly.  Reduction in mean arterial pressure at the end of 1 hour will be assessed.

Study Population and source of data**:**  patients presenting to Emergency department, JSS hospital, Mysuru with hypertensive acute pulmonary edema satisfying the inclusion and exclusion criteria

Subject Eligibility:

a) Inclusion Criteria:

•      Age> 18 years

•       Clinical presentation of acute pulmonary edema-

RR>30cpm

Spo2<90 in room air (oxygen requirement)

Coarse crepitations on auscultation

B profile on Point of care lung ultrasound

•      Elevated BP(SBP>180 mmHg)

b) Exclusion Criteria:

·         Pregnant patients (positive urine or serum B-HCG)

·         Aortic dissection

·         Eclampsia

·         intracranial hemorrhage

·         Patients already on non NTG vasoactive medications

·         Nitroglycerine allergy

Study Assessments of endpoints:

Reduction of 25% mean arterial pressure from the initial SBP in patients with acute pulmonary edema presenting to the Emergency Department are assessed by  measuring blood pressure at regular intervals of 5 minutes for 1 hour.

Study conduct:

 Patient’s data will be collected on a semi-structured proforma and data extracted will include:

·         Demographic details

·         Comorbidities/clinical history

·         Medication history

·         Consent form

·         Vitals at presentation

·         Usage of other drugs and interventions (NIPPV/diuretics)

Study Treatment:

High dose group: Intravenous.Nitroglycerine 100mcg/min iv infusion

Low dose group:  Intravenous.Nitroglycerine 5mcg/min iv infusion

Adverse Events: The major risk is Hypotension which can be avoided by continuous monitoring of BP and counteracted by stopping nitroglycerine and starting vasopressors.