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High dose NTG vs low dose NTG in the management of Sympathetic Crashing Acute Pulmonary Edema(SCAPE)

High dose vs low dose Nitroglycerin in Sympathetic Crashing Acute Pulmonary Edema(SCAPE): A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037902
Enrollment
50
Registered
2021-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems Health Condition 2: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: High Dose Nitroglycerin(NTG): NTG IV Bolus based on Systolic Blood pressure-600mcg to 1000mcg followed by IV infusion 100mcg/min with increment of 20mcg/min every 10min if symptoms pers

Sponsors

Department of Emergency Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adults ( more than or equal to 18 years ) presenting to ED with 1.BP more than or equal to 160/100 mmHg 2.Acute shortness of breath (within 6 hrs ) 3.Respiratory Rate more than or equal to 30/min 4.SpO2 less than or equal to 90% 5.Bilateral crepitations in all pulmonary areas 2)Patients / Legally authorised representative willing to give valid consent

Exclusion criteria

Exclusion criteria: 1)Patients / Legally authorized representative unable or unwilling to give informed consent. 2)Patients brought in Cardio- Respiratory Arrest 3)History of trauma 4)Age less than 18 years 5)Patients with associated ACS 6)History of hypersensitivity to NTG 7)Use of Phosphodiesterase V inhibitors within 48 hours 8)Patients with moderate to severe AS, HOCM

Design outcomes

Primary

MeasureTime frame
A. To compare the resolution of symptoms (outcome) at 6 hours, 12 hours after presentation to Emergency Department in both arms i.e Any 2 out of 4 1. Respiratory Rate decrease by 25% 2. Respiratory Rate less than or equal to 24 /min 3. SBp less than 160 mmHg 4. Subjective improvement B. To assess the need of Invasive Mechanical Ventilation in both arms Timepoint: 6 hours and 12 hours after presenting to ED

Secondary

MeasureTime frame
1. To compare serum -Troponin I, serum-NT- pro BNP, B line score in POCUS in both arms at the onset and after the treatment. 2. To compare the number of ICU admissions. 3. To assess MACE ( Major Adverse Cardiovascular Events ) and MAKE ( Major adverse Kidney Events ) at 30 days Timepoint: At the time of Onset to ED and after the treatment

Countries

India

Contacts

Public ContactDr Nayer Jamshed

AIIMS,New Delhi

jamshednayer@gmail.com9990345682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026