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Fluid and Nutrition in Elective Hip Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Hahn, Sodertalje Hospital
ClinicalTrials.gov Identifier:
NCT01211184
First received: September 28, 2010
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hip Surgery Corrective
Interventions: Drug: Water administration
Dietary Supplement: carbohydrate drink
Behavioral: Fasting.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Information about the study, exclusion criteriae were applied to potential subjects

Reporting Groups
  Description
Fasting patients undergo surgery in the fasting state
Water Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
Carbohydrate Drink Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth

Participant Flow:   Overall Study
    Fasting     Water     Carbohydrate Drink  
STARTED     20     20     20  
COMPLETED     20     18     19  
NOT COMPLETED     0     2     1  
Withdrawal by Subject                 0                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Fasting patients undergo surgery in the fasting state
Water Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
Carbohydrate Drink Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
Total Total of all reporting groups

Baseline Measures
    Fasting     Water     Carbohydrate Drink     Total  
Number of Participants  
[units: participants]
 		  20     20     20     60  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     7     7     11     25  
>=65 years     13     13     9     35  
Age  
[units: years]
Mean ± Standard Deviation 		  68.5  ± 9.6     66.4  ± 10.6     65.2  ± 8.0     66.9  ± 9.8  
Gender  
[units: participants]
 		       
Female     17     13     12     42  
Male     3     7     8     18  
Region of Enrollment  
[units: participants]
 		       
Sweden     20     20     20     60  



  Outcome Measures
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1.  Primary:   Change in Insulin Resistance (Percent)   [ Time Frame: Day before surgery (approxmtaley 3 PM) and in the morning after surgery (approx. 7.30 AM). ]
  Show Outcome Measure 1

2.  Secondary:   Muscle Catabolism   [ Time Frame: From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30) ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A few glucose tolerance tests had to be discarded because of hemolysis in the samples taken for analysis of insulin.  


Results Point of Contact:  
Name/Title: Robert Hahn
Organization: Södertälje Hospital
phone: +46855024670 ext 4670
e-mail: robert.hahn@sodertaljesjukhus.se


No publications provided by Sodertalje Hospital

Publications automatically indexed to this study:


Responsible Party: Robert Hahn, Sodertalje Hospital
ClinicalTrials.gov Identifier: NCT01211184     History of Changes
Other Study ID Numbers: STS1
Study First Received: September 28, 2010
Results First Received: September 12, 2011
Last Updated: November 8, 2011
Health Authority: Sweden: Institutional Review Board