Efficacy of midodrine for the prevention of orthostatic hypotension during early mobilization after fast-track hip arthroplasty - a randomized, placebo controlled trial

INTERVENTION: Trade Name: Gutron 5 mg Product Name: Gutron Pharmaceutical Form: Tablet INN or Proposed INN: MIDODRINE HYDROCHLORIDE CAS Number: 3092‐17‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Postoperative orthostatic hypotension during early mobilization after fast‐track hip arthroplasty ; MedDRA version: 14.1 Level: LLT Classification code 10021100 Term: Hypotension orthostatic System Organ Class: 10047065 ‐ Vascular disorders ; MedDRA version: 14.1 Level: LLT Classification code 10021102 Term: Hypotension orthostatic symptomatic System Organ Class: 10047065 ‐ Vascular disorders ; MedDRA version: 14.1 Level: LLT Classification code 10050632 Term: Postoperative hypotension System Organ Class: 10022117 ‐ Injury, poisoning and procedural complications ; MedDRA version: 14.1 Level: LLT Classification code 10036433 Term: Postural hypotension System Organ Class: 10047065 ‐ Vascular disorders ; MedDRA version: 14.1 Level: PT Classification code 10031127 Term: Orthostatic hypotension System Organ Class: 10047065 ‐ Vascular disorders Therapeutic area: Body processes [G] ‐ Circulatory and Respiratory Physiological Phenomena [G09] PRIMARY OUTCOME: Main Objective: To examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty. Primary end point(s): 50% reduction in the incidence of orthostatic hypotension during mobilization 6 h after surgery. Secondary Objective: To examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on:; ‐the incidence of orthostatic intolerance 6 h after surgery; ‐the incidences of orthostatic hypotension and intolerance 24 h after surgery; ‐the haemodynamic response to mobilization 6‐ and 24 h after surgery.; ‐Side effects (pruritus, headache, supine orthostatic hypertension, urinary retention) Timepoint(s) of evaluation of this end point: 6 hours after surgery SECONDARY OUTCOME: Secondary end point(s): ‐the incidence of orthostatic intolerance 6 h after surgery; ‐the incidences of orthostatic hypotension and intolerance 24 h after surgery; ‐the haemodynamic response to mobilization 6‐ and 24 h after surgery.; ‐Side effects (pruritus, headache, supine orthostatic hypertension, urinary retention) Timepoint(s) of evaluation of this end point: 6 and 24 h after surgery. INCLUSION CRITERIA: ‐Scheduled for primary unilateral hip arhtroplasty in one of the participating centers ‐Age >= 18 years ‐Able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80