Trial Outcomes & Findings for Fluid and Nutrition in Elective Hip Surgery (NCT NCT01211184)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).

Results posted on

2016-11-25

Participant Flow

60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009

Information about the study, exclusion criteriae were applied to potential subjects

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	18	19
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	0	2	1

Baseline Characteristics

Fluid and Nutrition in Elective Hip Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fasting n=20 Participants patients undergo surgery in the fasting state	Water n=20 Participants Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery	Carbohydrate Drink n=20 Participants Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants
Age, Continuous	68.5 years STANDARD_DEVIATION 9.6 • n=5 Participants	66.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	65.2 years STANDARD_DEVIATION 8.0 • n=5 Participants	66.9 years STANDARD_DEVIATION 9.8 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment Sweden	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).

Population: Per protocol analysis. The study was powered to detect a difference in glucose clearance.

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

Outcome measures

Outcome measures
Measure	Fasting Group n=16 Participants Patients did not ingest any drink or food from midnight before the surgery.	Water Group n=14 Participants Patients drank 800 ml of tap water 2 hrs before entering the operating room	Nutrition Group n=15 Participants Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
Change in Insulin Sensitivity (Percent)	-43 percent change of insulin sensitivity Interval -77.0 to 19.0	-38 percent change of insulin sensitivity Interval -82.0 to -20.0	-51 percent change of insulin sensitivity Interval -74.0 to 0.0

SECONDARY outcome

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

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Fasting Group n=20 Participants Patients did not ingest any drink or food from midnight before the surgery.	Water Group n=19 Participants Patients drank 800 ml of tap water 2 hrs before entering the operating room	Nutrition Group n=18 Participants Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
Muscle Catabolism	18.0 mmol/mmol Standard Deviation 2.0	17.3 mmol/mmol Standard Deviation 2.6	17.5 mmol/mmol Standard Deviation 2.7

Adverse Events

Fasting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carbohydrate Drink

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Hahn

Södertälje Hospital

Phone: +46855024670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place