Assessment of the β-alanine effect on postoperative clinical outcomes in patients with acute lower and upper extremity ischemia
Design
This randomized-controlled parallel, double-blind clinical trial study, phase 3 will be conducted on 40 patients. The randomization will be done with a stratified block randomization method using Random Allocation Software.
Settings and conduct
In this double-blind clinical trial study, patients with acute lower and upper extremity ischemia undergoing surgery in Urmia Imam Khomeini hospital will be enrolled. The patients will be divided randomly into intervention or placebo groups. Patients in the intervention group will be received 4 gr of oral β-alanine before surgery and 4 hours after surgery. Patients in the placebo group will be received 4 gr of placebo in addition to routine treatment.
Participants/Inclusion and exclusion criteria
In this study, the patients with acute lower and upper extremity ischemia who have surgical indication and the possibility of limb preservation will be enrolled. The exclusion criteria will be including gangrene of the limbs, motlelling of the limbs, Indication of amputation, and renal failure diseases.
Intervention groups
Patients in the intervention group will be received 4 gr of oral β-alanine before surgery and 4 hours after surgery. Patients in the placebo group will be received 4 gr of placebo in addition to routine treatment.
Main outcome variables
Frequency and vastness of limbs loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N5
Registration date:2022-05-04, 1401/02/14
Registration timing:prospective
Last update:2022-05-04, 1401/02/14
Update count:0
Registration date
2022-05-04, 1401/02/14
Registrant information
Name
Naser Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 9924
Email address
masoudi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the β-alanine effect on postoperative clinical outcomes in patients with acute lower and upper extremity ischemia
Public title
Assessment of the β-alanine effect in acute lower and upper extremity ischemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute extremity ischemia patients
Having surgical indications and the possibility of limb preservation
Exclusion criteria:
Gangrene of the limbs
Motlelling of the limbs
Amputation Indication
Renal failure diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and placebo groups using stratified block randomization based on generated numbers by random allocation software. Firstly, patients will be stratified according to the duration of thrombectomy or embolectomy into 1-2, 4-2, and 6-4 and more than 6 hours groups, and then block randomization will be performed in each stratum. So that, in this software, the number of groups (two groups including intervention or placebo) and the sample size in each stratum (for example in 1-2 stratum of the duration of thrombectomy or embolectomy) will be entered, and then in the block section, the block randomization method will be implemented. In each stratum, patients will be allocated to intervention or placebo groups based on generated numbers.
Random Allocation Software version 1.0.0 has been developed by Mr.Saghaei, MD. department of anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blinded to the intervention or placebo groups. Beta-alanine and placebo will be given to the patient by another surgeon (other than the researcher ) and the placebo tablets will be similar to the Beta-alanine tablets in shape and size. Group names will be encoded with the letters A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences
Intervention group: Patients in the intervention group will be received 4 gr of oral β-alanine before surgery and 4 hours after surgery. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery.
Category
Treatment - Other
2
Description
Control group: Patients in the placebo group will receive 4 gr of placebo before surgery and 4 hours after surgery in addition to routine treatment. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery.