Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408913510687 Date of Approval: 16/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Anabolic Steroid Use on muscle strength and weight gain in Critically Ill Non-Ventilated Patients. A Randomized Controlled Double Blind Study
Official scientific title Effects of Anabolic Steroid Use on muscle strength and weight gain in Critically Ill Non-Ventilated Patients. A Randomized Controlled Double Blind Study
Brief summary describing the background and objectives of the trial The occurrence of muscle weakness and malnutrition are two significant challenges in critical care settings, with an estimated prevalence of 30-50% during hospital stays. Critical conditions, such as Intensive Care Unit -acquired weakness (ICU-AW) and ICU-acquired diaphragm dysfunction (ICU-DD), frequently manifest in critically ill patients undergoing mechanical ventilation, influencing clinical outcomes. ICU-AW is a multifactorial disorder, attributed to factors like drug side effects, disruption of microcirculation, and muscle atrophy from prolonged immobilization. Catabolic processes, particularly myosin catabolism, contribute to muscle mass loss, exacerbating the situation. The metabolic responses to injury, including a pronounced catabolic response in critically ill patients, result in significant inflammatory and stress reactions, leading to the loss of lean body mass, muscular weakness, tachycardia, and diminished energy. Static responses, such as muscular atrophy, further impact outcomes, including increased mortality and extended hospital stays. To address ICU-AW, novel treatment strategies emphasize early mobilization, reduced sedation, and improved nutrition. Anabolic support during the recovery stage, including testosterone therapy, has been proposed. Testosterone deficiency is common in critically ill patients, indicating a hormonal imbalance during acute illness. While testosterone therapy in healthy males has demonstrated benefits in physical functioning, including increased fat-free mass and muscle strength, it poses virializing side effects for women and adverse impacts on cholesterol levels . Other anabolic agents, such as Decadurabolin and oxandrolone, exhibit more significant effects on muscle strength with minimal androgenic effects. Few studies investigated the potential benefits of intramuscular Decadurabolin administration on the muscle thickness and strength .Some studies reported that intramuscular Decadurabolin administration increased the muscle thickness and strength and other studies denied this, so we designed this study to judge the effect of intramuscular Decadurabolin administration on muscle weakness in critically ill patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/05/2024
Actual trial start date 01/06/2024
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sterile water as a Placebo 5ml of sterile water three doses for three weeks 20 patients will receive Intramuscular doses of Placebo administered into the lateral thigh weekly for up to three doses. All the patients fulfilling the inclusion criteria will be fully examined ,routine labs will be done. All these patients will be assessed for muscle weakness, weight loss and catabolic state 20 Placebo
Experimental Group Intramuscular doses of Decadurabolin Female participants will receive 100 mg(2ml), and males will receive 200 mg. Intramuscular doses of Decadurabolin administered into the lateral thigh weekly for up to three doses 20 patients will receive Intramuscular doses of Decadurabolin administered into the lateral thigh weekly for up to three doses. All the patients fulfilling the inclusion criteria will be fully examined ,routine labs will be done and All these patients will be assessed for muscle weakness, weight loss and catabolic state 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients admitted to ICU for more than 2 weeks, who has significant muscle weakness or weight loss more than 10% due to ICU stay despite participating in physiotherapy program and receiving full nutritional support. • Intercurrent shock state • Prostate or breast cancer. • Active cardiac condition (EF<35%, or recent MI) • Ongoing non-curable reason for catabolic state (active malignancy, HIV). • Pregnancy • Nephrotic syndrome • Elevated LFTs (ALT > 5-times normal ranges) • Coagulopathy (INR >1.5 OR Platelets < 50) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/05/2024 menoufia university faculty of medicine ethical commitee
Ethics Committee Address
Street address City Postal code Country
Yassin abdelgaffar street Shebeen Elkoom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study aims to explore potential benefits and safety of administration of anabolic steroid Decadurabolin to critically ill patients having muscle weakness. Primary outcome: to assess Quadriceps femoris muscle thickness (ultrasound guided) four times during time interval of the study four time points : before intervention drug and every week after intervention for three weeks
Secondary Outcome • Length of ICU stay • ICU mortality • Improvement of muscle weakness • Weight gain • Diaphragmatic muscle thickness weight gain and diaphragmatic muscle thickness will be assessed four time points but length of ICU stay and ICU mortality measured once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospitals Yassin abdelghaffar street Shebeen Elkoom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding no adress no funding Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor no sponsor yassin abdelghaffar street Shebeen Elkoom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Esmail Monaesmail225@gmail.com 00201501422433 Shebeen Elkoom
City Postal code Country Position/Affiliation
Shebeen Elkoom 32511 Egypt resident
Role Name Email Phone Street address
Scientific Enquiries Hanady Elfeky hanadymhmmd@gmail.com 00201068004428 Shebeen Elkoom
City Postal code Country Position/Affiliation
Shebeen elkoom 32511 Egypt lecturere
Role Name Email Phone Street address
Public Enquiries Nagwa Mohamed nagwamohameddoha@yahoo.com 00201006235642 Shebeen Elkoom
City Postal code Country Position/Affiliation
Shebeen Elkoom 32511 Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Immediately following publication, No end date Study Protocol not available not available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information