E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative orthostatic hypotension during early mobilization after fast-track hip arthroplasty |
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E.1.1.1 | Medical condition in easily understood language |
Low blood pressure during standing after hip surgery |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021100 |
E.1.2 | Term | Hypotension orthostatic |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021102 |
E.1.2 | Term | Hypotension orthostatic symptomatic |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050632 |
E.1.2 | Term | Postoperative hypotension |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036433 |
E.1.2 | Term | Postural hypotension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031127 |
E.1.2 | Term | Orthostatic hypotension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Scheduled for primary unilateral hip arhtroplasty in one of the participating centers -Age >= 18 years -Able to give informed consent |
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E.4 | Principal exclusion criteria |
- General anaesthesia for the current procedure - Digoxin treatment. - history of renal or hepatic failure - history of glaucoma - history chronic urinary retention requiring treatment - history of orthostatic intolerance / hypotension - other autonomous nervous system disease - alcohol or drug abuse - current malignant disease - females in the fertile age (possible pregnancy or breast feeding) - Treatment with anticoagulants - BMI > 40 kg/m2 - Dementia or cognitive dysfunction (investigators evaluation)
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E.5 End points |
E.5.1 | Primary end point(s) |
50% reduction in the incidence of orthostatic hypotension during mobilization 6 h after surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 and 24 h after surgery. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Inclusion of 120 patients who have fulfilled the study prototcol for the designated study period (last patient - last visit) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |