Hip Surgery Corrective Clinical Trial
Official title:
Fluid and Nutrition in Elective Hip Surgery
| Verified date | December 2011 |
| Source | Sodertalje Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to determine whether fluid or glucose administration before hip replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Södertälje Hospital | Södertälje |
| Lead Sponsor | Collaborator |
|---|---|
| Sodertalje Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Insulin Sensitivity (Percent) | Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before | Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM). | No |
| Secondary | Muscle Catabolism | Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism. | From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30) | No |
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