Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001462370
Ethics application status
Approved
Date submitted
11/10/2017
Date registered
16/10/2017
Date last updated
16/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative nutritional status as a predictor of postoperative fatigue in patients undergoing cardiac or vascular surgery
Scientific title
Assessing the relationship between pre-operative nutritional status and post-operative fatigue in patients undergoing cardiac or vascular surgery
Secondary ID [1] 293109 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 305056 0
Nutritional Status 305057 0
Condition category
Condition code
Surgery 304377 304377 0 0
Other surgery
Diet and Nutrition 304401 304401 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants in the study were cardiac and vascular surgical patients admitted in the elective or acute setting at a tertiary public hospital (Waikato Hospital, New Zealand) between December 2008 and February 2009. Prior to surgery included participants completed two questionnaires: the Mini Nutritional Assessment (MNA) questionnaire and the Identity Consequences Fatigue Score (ICFS) questionnaire. The duration of observation was from surgical admission until 6 months post operatively.

The MNA questionnaire was used to screen for preoperative nutritional status and consisted of two sections: screening and assessment. Using a scoring system, the screening section assessed loss of appetite, weight loss, mobility, psychological stress, acute disease, neuropsychological problems and BMI. Patients were then allocated into “normal” and “possible malnutrition” subgroups. If classified as “possible malnutrition”, then the patient would complete a more detailed assessment section evaluating their dietary history, and psychosocial and health status, including both mid- arm and calf circumferences.

The ICFS measured self-reports of patient fatigue and, following preoperative completion, was then posted to participants for self-completion at 2 and 6 months postoperatively. Patients were contacted by phone to ensure receipt of questionnaires and a reminder phone call was conducted if a completed questionnaire was not received within a week, through a pre-paid envelope provided.
Intervention code [1] 299353 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303626 0
The relationship between pre-operative nutritional status and post-operative fatigue assessed using pre-operative nutritional status (assessed by the MNA questionnaire) and post-operative fatigue (assessed by the ICFS questionnaire).

Bi-serial-correlation tested the relationship between nutritional status (dichotomous variable: 0-11 possible malnutrition and 11-14 normal nutrition) and fatigue, due to the non-linear intervals on the scale. Unpaired t-tests identified variables for construction of multiple regression analyses, while association between categorical variables was investigated using Pearson’s chi-square statistics. Mixed ANOVA detected differences in mean measurements of fatigue between the two nutritional groups. In addition, repeated measures over the three time points and the interactional effect between time and nutritional status were analysed.
Timepoint [1] 303626 0
At 2 and 6 months post operatively
Primary outcome [2] 303627 0
Comparison of changes in the levels of post-operative fatigue for “normal” and “possible malnutrition” nutritional groups. Contrast analysis was performed to identify the significance of fatigue change between patients pre-operatively and 2 months postoperatively, as well as the change in fatigue between 2 and 6 months post-operatively.
Timepoint [2] 303627 0
Over 6 months post operatively
Secondary outcome [1] 339685 0
Assess the influence of nutritional and surgical variables on post-operative fatigue levels.

Multiple regression studies were constructed to identify nutritional status variables (as per the MNA and ICFS score) and other co-morbidities (including smoking status, pre-existing renal disease, major surgery and re-operation for vascular surgery) which best explained levels of fatigue. Variables were selected by first including all factors and then removing all that were not significant. Significance unless otherwise specified was defined as p<0.05.
Timepoint [1] 339685 0
At 2 and 6 months post operatively

Eligibility
Key inclusion criteria
Cardiac and vascular surgical patients admitted in the elective or acute setting at a tertiary public hospital (Waikato Hospital, New Zealand) between December 2008 and February 2009.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- under the age of 18
- had cancer or severe dementia.
- declined consent for the study

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data was compiled and analysed using SPSS version 22 software (IBM Corporation, Armonk, NY, USA) and GraphPad Prism 5.0. Bi-serial-correlation tested the relationship between nutritional status (dichotomous variable: 0-11 possible malnutrition and 11-14 normal nutrition) and fatigue, due to the non-linear intervals on the scale. Unpaired t-tests identified variables for construction of multiple regression analyses, while association between categorical variables was investigated using Pearson’s chi-square statistics. Mixed ANOVA detected differences in mean measurements of fatigue between the two nutritional groups. In addition, repeated measures over the three time points and the interactional effect between time and nutritional status were analysed. Contrast analysis was performed to identify the significance of fatigue change between patients pre-operatively and 2 months postoperatively, as well as the change in fatigue between 2 and 6 months post-operatively. Multiple regression studies were constructed to identify nutritional status and other co-morbidities which best explained levels of fatigue. Variables were selected by first including all factors and then removing all that were not significant. Significance unless otherwise specified was defined as p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
28/02/2009
Date of last data collection
Anticipated
Actual
30/09/2009
Sample size
Target
100
Accrual to date
Final
135
Recruitment outside Australia
Country [1] 9279 0
New Zealand
State/province [1] 9279 0
Hamilton

Funding & Sponsors
Funding source category [1] 297739 0
University
Name [1] 297739 0
Waikato Clinical School, University of Auckland
Country [1] 297739 0
New Zealand
Primary sponsor type
University
Name
Waikato Clinical School, University of Auckland
Address
Waikato Clinical Campus
Peter Rothwell Academic Centre
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 296772 0
None
Name [1] 296772 0
Address [1] 296772 0
Country [1] 296772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298802 0
Northern Y Ethics Committee
Ethics committee address [1] 298802 0
Ethics committee country [1] 298802 0
New Zealand
Date submitted for ethics approval [1] 298802 0
Approval date [1] 298802 0
08/08/2008
Ethics approval number [1] 298802 0
NTY/08/08/080

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78270 0
Dr Nathaniel Chiang
Address 78270 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
AUSTRALIA
Country 78270 0
Australia
Phone 78270 0
+61432602149
Fax 78270 0
Email 78270 0
[email protected]
Contact person for public queries
Name 78271 0
Nathaniel Chiang
Address 78271 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
AUSTRALIA
Country 78271 0
Australia
Phone 78271 0
+61432602149
Fax 78271 0
Email 78271 0
[email protected]
Contact person for scientific queries
Name 78272 0
Nathaniel Chiang
Address 78272 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
AUSTRALIA
Country 78272 0
Australia
Phone 78272 0
+61432602149
Fax 78272 0
Email 78272 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.