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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month, three months, six months, and twelve months after discharge
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital mortality
Secondary outcome measures
Heart rate
Incidence of tachydysrhythmia
Other outcome measures
Discharge location
Duration of mechanical ventilation
Functional status
+4 more

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.

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Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
818,955 Total Patients Enrolled
3 Trials studying Shock
110 Patients Enrolled for Shock
John P Kress, MDPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
1,314 Total Patients Enrolled
1 Trials studying Shock
83 Patients Enrolled for Shock

Media Library

Phenylephrine (Vasoconstrictor) Clinical Trial Eligibility Overview. Trial Name: NCT02118467 — Phase 4
Shock Research Study Groups: Norepinephrine and epinephrine, Phenylephrine and vasopressin
Shock Clinical Trial 2023: Phenylephrine Highlights & Side Effects. Trial Name: NCT02118467 — Phase 4
Phenylephrine (Vasoconstrictor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02118467 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with using Norepinephrine and epinephrine therapeutically?

"This approved treatment has been extensively tested, so its safety rating is a solid 3."

Answered by AI

What primary roles do Norepinephrine and epinephrine play in modern medical treatment?

"Norepinephrine and epinephrine are typically administered to treat uterine contractions, but they can also be of use for treating laryngotracheobronchitis, eye conditions, and cases of unresponsive bradycardia."

Answered by AI

How have Norepinephrine and epinephrine been tested in the past through scientific research?

"Currently, 71 studies are researching the efficacy of Norepinephrine and epinephrine medications. Of those active trials, 15 have entered Phase 3 testing. Though concentrated in Los Angeles, California - these clinical trials take place at 120 different locations across the USA."

Answered by AI

How many participants has this trial recruited thus far?

"Affirmative. The latest information on clinicaltrials.gov exhibits that this medical trial is actively enrolling participants, beginning from May 1st 2014 and last updated December 21 2022. 836 patients are needed for the research at one established site of study."

Answered by AI

Is this experiment recruiting participants currently?

"Affirmative. Clinicaltrials.gov has updated information that this experiment is presently enrolling participants, who were initially posted on May 1st 2014. 836 patients are intending to be recruited at one location."

Answered by AI
~46 spots leftby Dec 2024