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Vasoconstrictor

Vasoactive Drugs for Shock

Phase 4

Recruiting

Led By John P Kress, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Age greater than or equal to 18 years old

Must not have

Severe right heart failure

Cardiopulmonary arrest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month, three months, six months, and twelve months after discharge

Awards & highlights

Drug Has Already Been Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial is testing whether two drugs are better than two other drugs at reducing heart rhythm problems in people with shock who haven't responded to IV fluids.

Who is the study for?

This trial is for adults in the ICU with shock not improved by IV fluids, needing drugs through a central vein to manage blood pressure. It's not for those with severe right heart failure, cardiopulmonary arrest, or pregnant women.

What is being tested?

The study tests if phenylephrine and vasopressin can better reduce heart rhythm problems than norepinephrine and epinephrine in ICU patients with shock. It's a randomized double-blind trial where treatments are assigned by chance without patient or doctor knowing which one is given.

What are the potential side effects?

Vasoactive drugs like those tested may cause irregular heartbeat, changes in blood pressure, headache, chest pain, weakness and potential complications at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need strong medication through a vein for severe low blood pressure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe failure of the right side of my heart.

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I have never had a cardiopulmonary arrest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of tachydysrhythmia

Other study objectives

Discharge location

Functional status

ICU Complications

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Group I: Norepinephrine and epinephrineActive Control2 Interventions

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.

Group II: Phenylephrine and vasopressinActive Control2 Interventions

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.

0 / 4Eligibility criteria met