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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | Placebo Comparator | patients undergo surgery in the fasting state |
|
| Water administration | Active Comparator | Patients undergo hip surgery after receiving 800 ml water by mouth the morning 2 hours before surgery |
|
| carbohydrate drink | Active Comparator | Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water administration | Dietary Supplement | patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Hahn, Prof | Linkoeping University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södertälje Hospital | Södertälje | Södertälje | 15286 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22747890 | Derived | Ljunggren S, Hahn RG. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial. Trials. 2012 Jul 2;13:97. doi: 10.1186/1745-6215-13-97. |
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Results have been published in international journals. Main article is:
Ljunggren S, Hahn RG. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial. Trials 2012; 13: 97.
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Information about the study, exclusion criteriae were applied to potential subjects
60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Fasting | patients undergo surgery in the fasting state |
| FG001 | Water | Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery |
| FG002 | Carbohydrate Drink | Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fasting | patients undergo surgery in the fasting state |
| BG001 | Water | Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Per protocol analysis. The study was powered to detect a difference in glucose clearance. | Posted | Median | Inter-Quartile Range | percent change of insulin sensitivity | Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fasting | patients undergo surgery in the fasting state |
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A few glucose tolerance tests had to be discarded because of hemolysis in the samples taken for analysis of insulin.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Hahn | Södertälje Hospital | +46855024670 | 4670 | robert.hahn@sodertaljesjukhus.se |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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|
| carbohydrate drink | Dietary Supplement | 800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery |
|
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| Fasting. | Behavioral | The patient is fasting from midnight before the surgery. |
|
| BG002 | Carbohydrate Drink | Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients drank 800 ml of tap water 2 hrs before entering the operating room
| OG002 | Nutrition Group | Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp) |
|
|
| 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. | Per protocol | Posted | Mean | Standard Deviation | mmol/mmol | From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30) |
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|
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Water | Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery | 0 | 18 | 0 | 18 |
| EG002 | Carbohydrate Drink | Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth | 0 | 19 | 0 | 19 |
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