Status:

UNKNOWN

RaGuS Trial by Postoperative Patients

Lead Sponsor:

Bürgerspital Solothurn

Conditions:

Vasoplegic Syndrome

Sirs Due to Noninfectious Process Without Organ Dysfunction

Eligibility:

All Genders

18-99 years

Phase:

PHASE4

Brief Summary

Vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output. It is principally observed in cardiovascular and orthopedic intervention...

Detailed Description

Midodrine is an alpha 1 receptor agonist used usually in cases of hypotension helping to increase blood pressure. The main indication is orthostatic hypotension but there are other clinical conditions...

Eligibility Criteria

Inclusion

  • Over 18 years of age
  • Need of vasoactive drugs after three hours from arrival and adequate volume recovery.

Exclusion

  • Signs of infection (anamnesis or pro-calcitonin \> 0.2 with leukocytosis, CRP and/or fever)
  • Serum lactate \> 2mmol/l
  • Mechanical ventilation
  • Therapeutic restrictions or comfort measures at arrival
  • "de novo" or acute on chronic heart failure (Reduction of known ejection fraction for more than 20 percent, signs of acute lung edema)
  • Pregnant
  • Patients with digoxin treatment or history of glaucoma.
  • History of midodrine allergy, pheochromocytoma, thyrotoxicosis, tachyarrhythmias or ventricular fibrillation.

Key Trial Info

Start Date :

September 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 14 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04440085

Start Date

September 14 2020

End Date

September 14 2021

Last Update

June 19 2020

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