RECRUITING

Use of Midodrine in Septic Shock Patients

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Conditions

SepsisLow Blood PressureVasopressors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.

Official Title

Use of Midodrine in Septic Shock Patients

Quick Facts

Study Start:2024-05-14
Study Completion:2029-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06319248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sepsis-3 criteria: acute hospital admission for suspected infection with new or worsening organ dysfunction measured by the increase in Sequential Organ failure Assessment (SOFA) score of 2 points or more.
  2. * IV vasopressor use or persistent hypotension (MAP \< 65 mm Hg) after initial fluid resuscitation in the ED or ICU (30 mL/kg unless deemed excessive by the treating clinician).
  1. * High-dose vasopressors (norepinephrine equivalent \> 0.3 µg/kg/min).
  2. * Inadequately controlled source of infection.
  3. * Cardiogenic or obstructive (massive pulmonary embolism) shock.
  4. * Clinical suspicion or confirmed diagnosis of bowel obstruction, bowel ischemia, or ileus.
  5. * Contraindication to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures etc.).
  6. * Recent myocardial infarction (within the past 3 months).
  7. * Recent treatment for peripheral vascular disease (within the past 3 months).
  8. * Current use of monoamine oxidase inhibitors.
  9. * Recent stroke (within the past 3 months).
  10. * Prior use of midodrine as a home medication.
  11. * Known allergy to midodrine.
  12. * Comfort care measures.
  13. * Pregnancy.
  14. * Fludrocortisone acetate as a current home medication.
  15. * Bradycardia (heart rate \< 50 beats/min).
  16. * Untreated pheochromocytoma.
  17. * Untreated thyrotoxicosis.
  18. * Open-angle glaucoma.
  19. * Treating emergency or critical care physician unwilling to enroll patient in trial.
  20. * Inability to give consent for participation and no representative or surrogate available to consent.

Contacts and Locations

Study Contact

Aysun Tekin, M.D., M.S.
CONTACT
507-266-1273
Tekin.Aysun@mayo.edu

Principal Investigator

Amos Lal, MBBS
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Amos Lal, MBBS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14
Study Completion Date2029-07-30

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2029-07-30

Terms related to this study

Keywords Provided by Researchers

  • Vasopressors

Additional Relevant MeSH Terms

  • Sepsis
  • Low Blood Pressure