Vasoactive Drugs in Intensive Care Unit

NCT02118467 | Recruiting Phase 4 DMC

• 1 other identifier: 14-0047
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to norepinephrine and epinephrine. To investigate this hypothesis, the investigators are conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV fluids. All patients admitted to the adult intensive care units at the University of Chicago will be screened for eligibility.

Conditions

Shock

Keywords

Shock; Vasopressor agents; Norepinephrine; Epinephrine; Phenylephrine; Vasopressin; Atrial fibrillation; Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Six months

Secondary Outcomes (2)

• Heart rate

  Six months

• Incidence of tachydysrhythmia

  SIx months

Other Outcomes (7)

• Hospital length of stay

  Six months

• Discharge location

  Six months

• ICU Complications

  Six months

Study Arms (2)

Norepinephrine and epinephrine

ACTIVE COMPARATOR

Patients will receive norepinephrine infusion per standard protocol. Dose range will be 0.03-0.3 mcg/kg/minute. Norepinephrine concentration will be 16 mg/250 mL. If a second vasopressor is required, epinephrine will be added. Dose range of epinephrine will be 0.03-0.3 mcg/kg/minute. Epinephrine concentration will be 16 mg/250 mL. The drugs norepinephrine and epinephrine will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL/hr; this will allow the bedside nurse to program the medication per standard protocol. If the patient's shock is not adequately treated with the highest doses of both norepinephrine and epinephrine, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.

Drug: Norepinephrine; Drug: Epinephrine

Phenylephrine and vasopressin

ACTIVE COMPARATOR

Patients will receive phenylephrine infusion per standard protocol. Dose range will be 0.3 to 3.0 mcg/kg/minute. Phenylephrine concentration will be 160 mg/250 mL. If a second vasopressor is required, vasopressin will be added. Dose range of vasopressin will be 0.1 to 0.6 milliunits/kg/minute. Vasopressin concentration will be 40 units/250 mL. The drugs phenylephrine and vasopressin will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL/hr; this will allow the bedside nurse to program the medication per standard protocol. If the patient's shock is not adequately treated with the highest doses of both phenylephrine and vasopressin, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.

Drug: Phenylephrine; Drug: Vasopressin

Interventions

Norepinephrine DRUG

Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.

Also known as: Levophed

Norepinephrine and epinephrine

Epinephrine DRUG

Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.

Norepinephrine and epinephrine

Phenylephrine DRUG

Dose range 0.3 to 3.0 mcg/kg/minute, titrated to target blood pressure.

Also known as: Neo-Synephrine

Phenylephrine and vasopressin

Vasopressin DRUG

Dose range 0.1 to 0.6 milliunits/kg/minute, titrated to target blood pressure.

Also known as: Pitressin

Phenylephrine and vasopressin

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years old
• Requirement for vasoactive drugs via a central venous catheter for the treatment of shock. Shock will be defined as mean arterial pressure less than 70 mmHg or systolic blood pressure less than 100 mmHg despite administration of at least 1000 mL of crystalloid or 500 mL of colloid, unless there is an elevation in the central venous pressure to \> 12 mmHg or in the pulmonary artery occlusion pressure to \> 14 mmHg coupled with signs of tissue hypoperfusion (e.g. altered mental state, mottled skin, urine output \< 0.5 mL/kg body weight for one hour, or a serum lactate level of \> 2 mmol per liter).

You may not qualify if:

• Cardiopulmonary arrest
• Pregnancy
• Severe right heart failure

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Shock; Diabetes Insipidus; Atrial Fibrillation; Tachycardia

Interventions

Norepinephrine; Epinephrine; Phenylephrine; Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• John P Kress, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John P Kress, MD

CONTACT

773-702-6404; jkress@medicine.bsd.uchicago.edu

Anne Pohlman

CONTACT

6302487461; apohlman@medicine.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 21, 2014
• Study Start: May 15, 2014
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Locations

US (1)