RaGuS Trial by Postoperative Patients (RaGuS)
Vasoplegic Syndrome, Sirs Due to Noninfectious Process Without Organ Dysfunction, Orthostatic Hypotension
About this trial
This is an interventional treatment trial for Vasoplegic Syndrome focused on measuring Midodrine, Vasoplegic syndrome, Noradrenaline, SIRS
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Need of vasoactive drugs after three hours from arrival and adequate volume recovery.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention group
Control group
Midodrine will be administered every 8 hours, increasing the dose gradually until a maximum of 30 mg a day is reached. It will be given orally in the following sequence: 2.5 mg - 5 mg - 7.5 mg - 10 mg. The target standard perfusion pressure for all the patients will be a mean arterial pressure (MAP) > 65 mmHg, with unchanged dose of midodrine after target pressure is reached. If the pressure continues to increase, the same sequence will be followed for dose de-escalation.
By placebo group will be followed the same strategy.The target standard perfusion pressure for all the patients will be a mean arterial pressure (MAP) > 65 mmHg, with unchanged dose of placebo after target pressure is reached. If the pressure continues to increase, the same sequence will be followed for dose de-escalation.