RaGuS Trial by Postoperative Patients
Atslēgvārdi
Abstrakts
Apraksts
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 where this medicament is often used like hypotension by dialysis, hepatorenal syndrome and after carotid artery stenting.
Vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions. It produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection.
The investigators aim to conduct a randomized, double-blind, single-center, placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs (Noradrenalin).
Datumi
| Pēdējoreiz pārbaudīts: | 05/31/2020 |
| Pirmais iesniegtais: | 06/12/2020 |
| Paredzētā reģistrācija iesniegta: | 06/17/2020 |
| Pirmais izlikts: | 06/18/2020 |
| Pēdējais atjauninājums iesniegts: | 06/17/2020 |
| Pēdējā atjaunināšana ievietota: | 06/18/2020 |
| Faktiskais studiju sākuma datums: | 09/13/2020 |
| Paredzamais primārās pabeigšanas datums: | 09/29/2020 |
| Paredzamais pētījuma pabeigšanas datums: | 09/13/2021 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Intervention group
Drug: Control group
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Active Comparator: Intervention 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. | Drug: Intervention group All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Midodrine will be administered according to the evolution of the patient's mean pressure. |
| Placebo Comparator: Control group 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. | Drug: Control group All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Placebo will be administered according to the evolution of the patient's mean pressure. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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. |
Rezultāts
Primārie rezultāti
1. Time [aproximately 2 days]
Sekundārie iznākuma mērījumi
1. Length of stay [aproximately 7 days]
2. Vasopresors [aproximately 2 days]
3. Fluid balance [aproximately 2 days]
