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| ID | Type | Description | Link |
|---|---|---|---|
| ID: 2008-1240-31 | Other Identifier | Ethical Board of Karolinska Institute Stockholm |
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slow recruitment
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The investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. The primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.
The investigation is an open, randomized clinical study of individuals suffering from a proximal femoral fracture. The total study duration for each subject is approximately 12 months (+- 1 month); each patient will have 4'visits' (i.e. when PI extracts data to database) including regular praxis total: at registration; at discharge; 4 months and finally at 12 months after the surgery. For practical and logistic reasons, an interim-analysis will be conducted after approximately 100 patients whose data are completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine fluid treatment | Active Comparator | Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h and additionally as needed Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension |
|
| Goal directed haemodynamic treatment | Experimental | Goal directed haemodynamic treatment Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal directed haemodynamic treatment | Other | Treatment by fluids and Dobutamine to attain fixed haemodynamic goal |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with postoperative complications | absolute value, number | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively | 1 year |
| number of complications |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Erzsebet Bartha, M.D | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Huddinge | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26994228 | Derived | Bartha E, Arfwedson C, Imnell A, Kalman S. Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894). Br J Anaesth. 2016 Apr;116(4):486-92. doi: 10.1093/bja/aew025. | |
| 23837606 | Derived | Bartha E, Davidson T, Brodtkorb TH, Carlsson P, Kalman S. Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients. Trials. 2013 Jul 9;14:205. doi: 10.1186/1745-6215-14-205. |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D000092526 | Proximal Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D005265 | Femoral Neck Fractures |
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| ID | Term |
|---|---|
| D004280 | Dobutamine |
| C485123 | HES 130-0.4 |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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| Routine fluid treatment | Other | Protocol guided fluid treatment used in the clinical routine |
|
|
absolute value number
| 4 months |
| number of complications | absolute value number | 12 months |
| health related quality of life | 4 months |
| health related quality of life | absolute value number | 12 months |
| haemodynamic parameters | monitor readings from LiDCO plus | baseline |
| D006620 |
| Hip Fractures |
| D025981 | Hip Injuries |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |