Hip Surgery Corrective
Conditions
Keywords
Hip surgery, Metabolism, Glucose, Body fluids, Complications
Brief summary
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.
Detailed description
1. How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery? 2. Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?
Interventions
DIETARY_SUPPLEMENTWater administration
patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.
DIETARY_SUPPLEMENTcarbohydrate drink
800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
BEHAVIORALFasting.
The patient is fasting from midnight before the surgery.
Sponsors
Sodertalje Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Patient scheduled for hip surgery.
Exclusion criteria
Endocrinological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity (Percent) | Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM). | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Catabolism | From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30) | 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. |
Countries
Sweden
Participant flow
Recruitment details
60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009
Pre-assignment details
Information about the study, exclusion criteriae were applied to potential subjects
Participants by arm
| Arm | Count |
|---|---|
| Fasting patients undergo surgery in the fasting state | 20 |
| Water Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery | 20 |
| Carbohydrate Drink Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Water | Carbohydrate Drink | Fasting | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 9 Participants | 13 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 11 Participants | 7 Participants | 25 Participants |
| Age, Continuous | 66.4 years STANDARD_DEVIATION 10.6 | 65.2 years STANDARD_DEVIATION 8 | 68.5 years STANDARD_DEVIATION 9.6 | 66.9 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Sweden | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 17 Participants | 42 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 | 0 / 19 |
Outcome results
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
Time frame: Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).
Population: Per protocol analysis. The study was powered to detect a difference in glucose clearance.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fasting Group | Change in Insulin Sensitivity (Percent) | -43 percent change of insulin sensitivity |
| Water Group | Change in Insulin Sensitivity (Percent) | -38 percent change of insulin sensitivity |
| Nutrition Group | Change in Insulin Sensitivity (Percent) | -51 percent change of insulin sensitivity |
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.
Time frame: From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Group | Muscle Catabolism | 18.0 mmol/mmol | Standard Deviation 2 |
| Water Group | Muscle Catabolism | 17.3 mmol/mmol | Standard Deviation 2.6 |
| Nutrition Group | Muscle Catabolism | 17.5 mmol/mmol | Standard Deviation 2.7 |