Fluid and Nutrition in Elective Hip Surgery

NCT01211184 | Completed Results

• 1 other identifier: STS1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Surgery Corrective

Keywords

Hip surgery; Metabolism; Glucose; Body fluids; Complications

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Muscle Catabolism

  From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)

Study Arms (3)

Fasting

PLACEBO COMPARATOR

patients undergo surgery in the fasting state

Behavioral: Fasting.

Water administration

ACTIVE COMPARATOR

Patients undergo hip surgery after receiving 800 ml water by mouth the morning 2 hours before surgery

Dietary Supplement: Water administration

carbohydrate drink

ACTIVE COMPARATOR

Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth

Dietary Supplement: carbohydrate drink

Interventions

Water administration DIETARY_SUPPLEMENT

patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.

Also known as: Tap water

Water administration

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

Also known as: PreOp Nutricia ( Nutricia Nordic AB)

carbohydrate drink

Fasting. BEHAVIORAL

The patient is fasting from midnight before the surgery.

Fasting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Sodertalje Hospital: lead

Study Sites (1)

Södertälje Hospital

Södertälje, Södertälje, 15286, Sweden

Location

Related Publications (1)

• 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.

  PMID: 22747890 DERIVED

MeSH Terms

Interventions

Angptl4 protein, mouse

Limitations and Caveats

A few glucose tolerance tests had to be discarded because of hemolysis in the samples taken for analysis of insulin.

Results Point of Contact

• Title: Robert Hahn
• Organization: Södertälje Hospital

robert.hahn@sodertaljesjukhus.se

+46855024670

Study Officials

• Robert G Hahn, Prof

  Linkoeping University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 25, 2016
• Results First Posted: December 13, 2011

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)