Clinical trial

Intravenous Epinephrine Bolus for Prevention of Postintubation Collapse in Intensive Care Septic Patients Predicted by Shock Index.

Name

FMASU R303/2023

Description

Endotracheal intubation is a lifesaving procedure that is performed in various settings within the hospital or even in the pre-hospital field. However, it can result in serious hemodynamic complications, such as post-intubation hypotension (PIH) and cardiac arrest. Push-dose pressor (PDP) is common practice for rapid hemodynamic correction in post-intubation hypotension. In this study the investigators will use intravenous Epinephrine bolus for prevention of post intubation collapse in septic patients predicted by shock index in intensive care unit.

Trial arms

Trial start

2023-08-01

Estimated PCD

2023-12-01

Trial end

2024-01-01

Status

Recruiting

Treatment

epinephrine

patients will receive epinephrine prepared as 10 ml syringe filled with 10 ml of epinephrine 10 mcg/ml. prepared by drawing 1ml epinephrine 1mg ampule into 9 ml saline then discarding 9 ml and adding another 9 ml saline. now the investigators have 10 ml of epinephrine 10 mcg/ ml (1:100,000), then 10 µg will be given intravenously every 2-minute starting before intubation and continue during and after intubation for 4 times or until the systolic blood pressure (SBP) will be at least 90 mmHg or the mean arterial pressure (MAP) 65 mmHg or greater or after 4th dose of epinephrine and still hypotensive vasopressor (norepinephrine 30 ng /kg/min.) will be added or increased.

Arms:

E group for epinephrine

isotonic fluid

patients will receive IV bolus isotonic fluid 500 ml

Arms:

Group (F)

Size

Primary endpoint

incidence of cardiac arrest during intubation

during and till 30 minutes after intubation

sever hypotension

during and till 30 minutes after intubation

Eligibility criteria

Inclusion Criteria: * septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) \> 0.9. Exclusion Criteria: * patient's family refusal, age \<18, pregnant, Patients with tachyarrhythmias, traumatic patients, patient with shock index \<0.9, ischemic heart patients, any comorbidities contraindicated to take epinephrine and allergic to epinephrine will be excluded from the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': ': septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) \\> 0.9.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

Updated at

2023-11-08

1 organization

2 products

1 indication

Organization

Product

Indication

Product