RaGuS Trial by Postoperative Patients (RaGuS)
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|ClinicalTrials.gov Identifier: NCT04440085|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Vasoplegic Syndrome Sirs Due to Noninfectious Process Without Organ Dysfunction Orthostatic Hypotension||Drug: Midodrine Hydrochloride Drug: Placebo||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Randomized, double-blind, single-center, placebo-controlled study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||RANDOMIZED CASE-CONTROLLED TRIAL ASSESSING MIDODRINE (GUTRON®) IN POSTOPERATIVE VASOPLEGIC PATIENTS|
|Estimated Study Start Date :||September 14, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 14, 2021|
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: Midodrine Hydrochloride
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.
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 [ Time Frame: aproximately 2 days ]Hours from initiation of treatment with midodrine to discharge from critical care area
- Length of stay [ Time Frame: aproximately 7 days ]days in critical care area and hospital
- Vasopresors [ Time Frame: aproximately 2 days ]Noradrenalin needed doses
- Fluid balance [ Time Frame: aproximately 2 days ]cumulative fluid balance in mililiter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440085
|Contact: Marcos Delgado, MD||+4132627 ext firstname.lastname@example.org|
|Contact: René Fahrner, MD||+4132627 ext email@example.com|
|Principal Investigator:||Marcos Delgado, MD||Bürgerspital Solothurn|