Fluid and Nutrition in Elective Hip Surgery

October 13, 2016 updated by: Robert Hahn, Sodertalje Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Södertälje, Sweden, 15286
        • Södertälje Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Fasting
patients undergo surgery in the fasting state
Behavioral: Fasting.
The patient is fasting from midnight before the surgery.
Active Comparator: Water administration
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 water by mouth in the morning before the surgery.
Other Names:
  • Tap water
Active Comparator: carbohydrate drink
Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
Dietary supplement: carbohydrate drink
800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
Other Names:
  • PreOp Nutricia ( Nutricia Nordic AB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Catabolism
Time Frame: 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.
From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sodertalje Hospital

Investigators

  • Study Chair: Robert G Hahn, Prof, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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