Epinephrine to Prevent Postintubation Collapse in Shocked ICU Patients

NCT06115473 | Unknown

• 1 other identifier: FMASU R303/2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shock

Outcome Measures

Primary Outcomes (2)

• incidence of cardiac arrest during intubation

  cardiac arrest

  during and till 30 minutes after intubation

• sever hypotension

  decrease \> 20% of baseline mean arterial blood pressure

  during and till 30 minutes after intubation

Secondary Outcomes (5)

• incidence of arrythmias

  during and till 30 minutes after intubation

• bradycardia

  during and till 30 minutes after intubation

• increased lactate

  lactate will be measured 1 hour after intubation

• need for or increase dose of postintubation vasopressor

  during and till 30 minutes after intubation

• decreased oxygen saturation

  during and till 30 minutes after intubation

Study Arms (2)

E group for epinephrine

ACTIVE COMPARATOR

In Group (E) 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.

Drug: epinephrine

Group (F)

PLACEBO COMPARATOR

In Group (F) patients will receive IV bolus isotonic fluid 500 ml as it is yet the standard method used before intubation

Drug: isotonic fluid

Interventions

epinephrine DRUG

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.

E group for epinephrine

isotonic fluid DRUG

patients will receive IV bolus isotonic fluid 500 ml

Group (F)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) \> 0.9.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals at Intensive care units department

Cairo, 1181, Egypt

RECRUITING

MeSH Terms

Conditions

Shock

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: : septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) \> 0.9.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-10

Locations

EG (1)