A Phase 4 interventional study of Midodrine Hydrochloride and Placebo in Vasoplegic Syndrome, Sirs Due to Noninfectious Process Without Organ Dysfunction and Orthostatic Hypotension, sponsored by Bürgerspital Solothurn. Status unknown. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-19.
Sponsored by Bürgerspital Solothurn · Phase 4, Interventional, and Treatment
Vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output. It is principally observed in cardiovascular and orthopedic interventions and is characterized by a systemic inflammatory response with the inability of the vascular endothelial muscles to contract and a resistance to the action of vasoactive drugs. This event extends the length of stay in the critical care area due to the need of vasoactive drugs.
The investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital.
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).
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's planned enrollment of 50 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Bürgerspital Solothurn is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Midodrine Hydrochloride
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: Placebo
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.
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.
Time
Hours from initiation of treatment with midodrine to discharge from critical care area
Time frame: aproximately 2 days
Length of stay
days in critical care area and hospital
Time frame: aproximately 7 days
Vasopresors
Noradrenalin needed doses
Time frame: aproximately 2 days
Fluid balance
cumulative fluid balance in mililiter
Time frame: aproximately 2 days
No study locations are listed for this record.
Plan to share: No — We have decided for the Trial not to share the participant Information.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midodrine
Bürgerspital Solothurn