Protocol summary
-
Study aim
-
Finding a better treatment and a more effective method in reducing the rate of postoperative hospitalization, readmission rate due to complications associated with peritrochantic fracture, mortality rate 30 days after surgery, one-year mortality rate and the mentioned complications.
-
Design
-
Two groups including control and intervention; each 45 participants; randomized with table
-
Settings and conduct
-
Ninety patients with peritrochantric fracture referred to Sina and Imam Khomeini Hospital in Tehran will be collected and complementary-placebo drug envelopes will be given to patients for up to 30 days.
The study is randomized and triple blind includes researcher and patient and pharmaceutical company.
-
Participants/Inclusion and exclusion criteria
-
Inclusion conditions: patients with intertroch fractures and femur neck and subtroch who will be referred to Sina Hospital or Imam Khomeini Hospital in Tehran.
Exclusion criteria: pregnancy; under 18 years of age; renal failure
-
Intervention groups
-
90 patients with peritrochanteric fracture were randomly divided into 2 intervention and control groups of 45 people each and received drug packets containing supplements or placebo. Laboratory and demographics and complications will be collected and compared before and one month after receiving the supplement.
-
Main outcome variables
-
Lymphocyte and CRP levels, Prealbumin and vitamin D levels - Quality of life - 30-day mortality - Interval between hospitalization and surgery - Delirium - Clinical venous thrombosis
General information
-
Reason for update
-
Correcting and updating the start and end date of the trial
-
Acronym
-
ERAS
-
IRCT registration information
-
IRCT registration number:
IRCT20230127057247N1
Registration date:
2023-08-12, 1402/05/21
Registration timing:
registered_while_recruiting
Last update:
2025-02-03, 1403/11/15
Update count:
2
-
Registration date
-
2023-08-12, 1402/05/21
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-08-01, 1402/05/10
-
Expected recruitment end date
-
2024-08-01, 1403/05/11
-
Actual recruitment start date
-
2023-08-01, 1402/05/10
-
Actual recruitment end date
-
2024-08-01, 1403/05/11
-
Trial completion date
-
2024-09-01, 1403/06/11
-
Scientific title
-
Effects of combined dietary supplementation of protein and creatine on outcomes and acceleration of postoperative recovery in patients with peritrochantic fracture: A double-blind interventional esoteric study
-
Public title
-
Effects of combined dietary supplementation of protein and creatine on outcomes in patients with peritrochanter fracture
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with Femur neck fracture or intertroch fracture or subtrochantric fracture
Exclusion criteria:
Under 18 y/o
Pregnancy
Renal failure
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
90
Actual sample size reached:
80
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple individual randomization with random numbers table
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
The supplement and placebo are blinded by the manufacturer in English letters and the patient, the executor, the researcher and the manufacturer are unaware of the complete collection of the fear and its data from receiving the supplement or placebo by the patient.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-09-23, 1401/07/01
-
Ethics committee reference number
-
IR.TUMS.IKHC.REC.1401.212
Health conditions studied
1
-
Description of health condition studied
-
Femoral neck fracture, intertroch fracture and subtroch of femoral fracture
-
ICD-10 code
-
S72.14
-
ICD-10 code description
-
Intertrochanteric fracture of femur
Primary outcomes
1
-
Description
-
Nutritional level by checking blood lymphocyte level changes
-
Timepoint
-
At the time of hospitalization and a month later
-
Method of measurement
-
Request for testing at the time of hospitalization and one month later
2
-
Description
-
Nutritional level by checking changes in blood albumin level
-
Timepoint
-
At the time of hospitalization and a month later
-
Method of measurement
-
Request for testing at the time of hospitalization and one month later
3
-
Description
-
Nutritional level by checking changes in blood CRP level
-
Timepoint
-
At the time of hospitalization and a month later
-
Method of measurement
-
Request for testing at the time of hospitalization and one month later
4
-
Description
-
Changes in quality of life and the ability to perform daily activities and walk
-
Timepoint
-
At the time of hospitalization and a month later
-
Method of measurement
-
Parker questionnaire
5
-
Description
-
30-day mortality
-
Timepoint
-
30 days after surgery
-
Method of measurement
-
questionnaire
6
-
Description
-
Time interval between hospitalization and surgery
-
Timepoint
-
Hospitalization day and surgery day
-
Method of measurement
-
questionnaire
7
-
Description
-
Complications occurred for the patient including delirium and clinical venous thrombosis
-
Timepoint
-
In 30 days after surgery
-
Method of measurement
-
questionnaire
Intervention groups
1
-
Description
-
Intervention group: including patients with pretrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referred to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases according to the randomization table, they were divided into 2 groups. In the intervention group, after collecting demographic information and The request for tests includes cbc-crp-albumin-pre-albumin. Depending on the location and type of fracture and the clinical conditions, the patient is subjected to internal surgical fixation, and then after discharge for one month, a daily dose of 30 mg protein sachets dissolved in water, which includes He consumed creatinine, essential amino acids and protein, and after a month, the patient will be asked for the aforementioned tests and will be analyzed.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: including patients with peritrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referring to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases, according to the randomization table, they were divided into 2 groups, in the control group, after collecting demographic information and Request for tests including cbc-crp-albumin-pre-albumin surgery depending on the location and type of fracture and the clinical conditions of the patient is subjected to internal surgical fixation and then after discharge for a month daily placebo protein sachets of 30 mg soluble in water which includes dextrose and after a month, the patient will be asked for the above-mentioned tests and will be analyzed. The table of the amount of starting the park before and after the surgery was completed for him in a comparative manner.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Not applicable
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable