Hip Surgery CorrectiveNCT01211184
Fluid and Nutrition in Elective Hip Surgery
A study testing Water administration, carbohydrate drink and Fasting. in people with Hip Surgery Corrective, run by Sodertalje Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Surgery Corrective
- What is being tested?
- Water administration, carbohydrate drink and Fasting.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- May 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery?
- Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?
- Conditions
- Hip Surgery Corrective
- Being tested
- Water administration, carbohydrate drink, Fasting.
- Keywords
- Hip surgery, Metabolism, Glucose, Body fluids, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water administrationDietary supplement
Also called Tap water
patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.
carbohydrate drinkDietary supplement
Also called PreOp Nutricia ( Nutricia Nordic AB)
800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
Fasting.Behavioural
The patient is fasting from midnight before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Placebo comparator | patients undergo surgery in the fasting state Receives: Behavioral: Fasting. |
| Water administration | Active comparator | Patients undergo hip surgery after receiving 800 ml water by mouth the morning 2 hours before surgery Receives: Dietary Supplement: Water administration |
| carbohydrate drink | Active comparator | Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth Receives: Dietary Supplement: carbohydrate drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).
Secondary outcomes (1)
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.
Measured: From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Surgery CorrectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodertalje Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hahn, Sodertalje Hospital
- Investigators
- Robert G Hahn, Prof, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211184
- Sponsor's protocol ID
- STS1
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2010
- Last updated
- 25 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22747890
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid and Nutrition in Elective Hip Surgery
- ClinicalTrials.gov ID
- NCT01211184
- Acronym / sponsor ID
- STS1
- Conditions
- Hip Surgery Corrective
- Keywords
- Hip surgery, Metabolism, Glucose, Body fluids, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sodertalje HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Posted 13 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery?
- Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting | Placebo comparator | Behavioral: Fasting.patients undergo surgery in the fasting state |
| Water administration | Active comparator | Dietary Supplement: Water administrationPatients undergo hip surgery after receiving 800 ml water by mouth the morning 2 hours before surgery |
| carbohydrate drink | Active comparator | Dietary Supplement: carbohydrate drinkPatients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water administrationAlso: Tap waterpatients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery. | Dietary supplement | Water administration |
| carbohydrate drinkAlso: PreOp Nutricia ( Nutricia Nordic AB)800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery | Dietary supplement | carbohydrate drink |
| Fasting.The patient is fasting from midnight before the surgery. | Behavioural | Fasting |
Primary outcome
Change in Insulin Sensitivity (Percent)
Time frame: 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
1 secondary outcome
Muscle Catabolism
Time frame: From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22747890Ljunggren 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.
- Individual participant dataSharing planned: 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.
Related trials for Hip Surgery Corrective
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Cerebral Palsy, Hip Surgery Corrective
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Hahn, Prof study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water administration, carbohydrate drink and Fasting. in people with Hip Surgery Corrective, run by Sodertalje Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Sensitivity (Percent) (time frame: Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.