An interventional study of Water administration and carbohydrate drink in Hip Surgery Corrective, sponsored by Sodertalje Hospital. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by Sodertalje Hospital · Not applicable, Interventional, and Prevention
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.
Sodertalje Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.
patients undergo surgery in the fasting state
Behavioral: Fasting.
Patients undergo hip surgery after receiving 800 ml water by mouth the morning 2 hours before surgery
Dietary Supplement: Water administration
Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
Dietary Supplement: carbohydrate drink
patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.
Also known as: Tap water
800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
Also known as: PreOp Nutricia ( Nutricia Nordic AB)
The patient is fasting from midnight before the surgery.
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).
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)
60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009
| Milestone | Fasting | Water | Carbohydrate Drink |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 18 | 19 |
| Not completed | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 1 |
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
| percent change of insulin sensitivity | Fasting Group | Water Group | Nutrition Group |
|---|---|---|---|
| Change in Insulin Sensitivity (Percent) | -43 (-77 to 19) | -38 (-82 to -20) | -51 (-74 to 0) |
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.
| mmol/mmol | Fasting | Water Group | Nutrition Group |
|---|---|---|---|
| Muscle Catabolism | 18.0 ± 2.0 | 17.3 ± 2.6 | 17.5 ± 2.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fasting | — | 0/20 (0%) | 0/20 (0%) |
| Water | — | 0/18 (0%) | 0/18 (0%) |
| Carbohydrate Drink | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Fasting | Water | Carbohydrate Drink | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 11 | 25 |
| >=65 years | 13 | 13 | 9 | 35 |
| Age, Continuous(years) | Fasting | Water | Carbohydrate Drink | Total |
|---|---|---|---|---|
| Mean | 68.5 ± 9.6 | 66.4 ± 10.6 | 65.2 ± 8.0 | 66.9 ± 9.8 |
| Sex: Female, Male(Participants) | Fasting | Water | Carbohydrate Drink | Total |
|---|---|---|---|---|
| Female | 17 | 13 | 12 | 42 |
| Male | 3 | 7 | 8 | 18 |
| Region of Enrollment(participants) | Fasting | Water | Carbohydrate Drink | Total |
|---|---|---|---|---|
| Sweden | 20 | 20 | 20 | 60 |
Plan to share: Yes — 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.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sodertalje Hospital