Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

NCT05355974 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: IRB-2022-43
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Conditions

Respiratory Failure; Hypotension and Shock; Hypotension on Induction; Intubation Complication; Anesthesia Intubation Complication

Keywords

mean arterial pressure; Rapid Sequence Intubation; vasopressor; Norepinephrine; Hypotension from Intubation

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Change in systolic blood pressure during rapid sequence intubation in mmHg.

  1 hour after Rapid Sequence Intubation

Secondary Outcomes (2)

• Change in serum creatinine (Acute Kidney Injury)

  24 hours after Rapid Sequence Intubation

• Acute Kidney Injury

  24 hours after Rapid Sequence Intubation

Study Arms (2)

Norepinephrine plus Isotonic Fluids

EXPERIMENTAL

The treatment group will receive a continuous infusion of norepinephrine at 0.10 mcg/kg/min started 2-5 minutes prior to Rapid Sequence Intubation (assuming normal systolic blood pressure 90-140mmHg) in addition to a standard fluid bolus of Lactated Ringers or Normal Saline or Plasmalyte at 999 mL/hr.

Drug: Norepinephrine; Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte

Isotonic Fluids

ACTIVE COMPARATOR

The control group will receive an infusion of Lactated Ringers or Normal Saline or Plasma-Lyte with at least 500 mL at 999 ml/hr 2-5 minutes prior to Rapid Sequence Intubation.

Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte

Interventions

Norepinephrine DRUG

Norepinephrine continuous infusion at 0.10 mcg/kg/min

Also known as: Levophed, Norepinephrine Bitartrate, Norepinephrine-Dextrose

Norepinephrine plus Isotonic Fluids

Lactated Ringers, Intravenous DRUG

500mL infusion run at 999mL/hr

Also known as: Ringer's Injection, Hartmann's Solution, LR

Isotonic Fluids; Norepinephrine plus Isotonic Fluids

normal saline DRUG

500mL infusion run at 999mL/hr

Also known as: NS, 0.9 percent Sodium Chloride

Isotonic Fluids; Norepinephrine plus Isotonic Fluids

Plasma-lyte DRUG

500mL infusion run at 999mL/hr

Also known as: Plasma-Lyte 148, Plasmalyte

Isotonic Fluids; Norepinephrine plus Isotonic Fluids

Eligibility Criteria

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

You may qualify if:

• Respiratory Failure Requiring Intubation

You may not qualify if:

• Pregnancy
• Patients intubated during code blue clinical scenarios
• Requiring surgical airway
• Failed intubations
• MAP less than 65 or Systolic Blood Pressure (SBP) less than 90mmHg pre-intubation
• Systolic blood pressure greater than 150mmHg
• Prisoners

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Miami Valley Hospital Premier Health

Dayton, Ohio, 45409, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypotension; Shock

Interventions

Norepinephrine; Ringer's Lactate; Saline Solution; Plasma-lyte 148; Plasmalyte A

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases; 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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Matthew Koroscil, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

• Yonatan Dollin, DO

  Wright State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 2, 2022
• Study Start: August 9, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)