Home » Trials » SLCTR/2024/037
A multicenter open-labelled randomized controlled trial to evaluate the effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in Leptospirosis pulmonary haemorrhage syndrome
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SLCTR Registration Number
SLCTR/2024/037
Date of Registration
The date of last modification
Nov 22, 2024
Scientific Title of Trial
A multicenter open-labelled randomized controlled trial to evaluate the effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in Leptospirosis pulmonary haemorrhage syndrome
Public Title of Trial
The effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in improving clinical outcome of patients with leptospirosis pulmonary haemorrhage syndrome
Disease or Health Condition(s) Studied
Leptospirosis pulmonary haemorrhage
Scientific Acronym
None
Public Acronym
None
Brief title
The effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in improving clinical outcome of patients with leptospirosis pulmonary haemorrhage syndrome
Universal Trial Number
U1111-1310-3997
Any other number(s) assigned to the trial and issuing authority
ERC 20/24
What is the research question being addressed?
Does combining moderate-dose or high-dose intravenous methylprednisolone and plasmapheresis improve outcome in leptospirosis pulmonary haemorrhage syndrome compared to plasmapheresis alone?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
Study will be conducted at Colombo South Teaching Hospital, National Hospital of Sri Lanka and Teaching Hospital Karapitiya.
A balanced design will be used meaning that each participant has an equal chance of being assigned to any of the three treatment arms (ratio 1:1:1). A centralized randomization system will be used. At each participating center, when a participant is deemed eligible and provides informed consent, the site contacts the central randomization unit. The randomization unit then assigns the participant to one of the three treatment arms using randomization codes prepared by an independent statistician.
Study participants fulfilling inclusion criteria will be randomly allocated to following treatment groups prior to initiation of therapy. 1. Control arm: Plasmapheresis alone 2. Intervention 1: Plasmapheresis and intravenous methylprednisolone 150mg daily for 3 days 3. Intervention 2: Plasmapheresis and intravenous methylprednisolone 1000mg daily for 3 days
Plasmapheresis will be done by exchanging one plasma volume with fresh frozen plasma, percentage replacement is 90-95%. Plasma volume of the patient is calculated automatically from the machine using the height, weight and haematocrit. Plasmapharesis will be done daily for 3 days.
In addition, standard of care; IV Ceftriaxone 1g BD for 7 days, Renal replacement therapy for acute kidney injury, respiratory support for pulmonary haemorrhage and blood product transfusions for coagulopathy will be continued as per the discretion of the treating clinician.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
All cause in-hospital mortality |
[ At hospital discharge or death ] |
Secondary outcome(s)
|
1.
Criteria for hospital-acquired infections: -Ventilator-associated pneumonia defined as having new or progressive infiltrates in chest radiograph with clinical/laboratory features suggestive of infection (leucocytosis, elevated C reactive protein, fever) in a patient on mechanical ventilator - Urosepsis: Clinical/laboratory features of new infection with positive urine culture or suggestive urinalysis - Catheter-related blood stream infections: Clinical/laboratory features of new infection with positive catheter and blood culture positivity from the same micro-organism - Cannula-site infection: Clinically apparent cannula site infection (local redness, warmth in a site of cannula placement |
[ At hospital discharge or death ] |
|
2.
Duration of respiratory support (length of mechanical ventilation, duration of HFNO/NIV therapy) |
[ At hospital discharge or death ] |
|
3.
Duration of ICU stay |
[ At hospital discharge or death ] |
|
4.
Duration of hospital stay |
[ At hospital discharge or death ] |
|
5.
Side effects of steroid therapy (hyperglycaemia, high blood pressure, hyponatraemia, peptic ulcer disease) |
[ At hospital discharge or death ] |
Target number/sample size
Total 84 (28 in each of the three arms)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-12-01
Anticipated end date
2027-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Funded from University of Sri Jayewardenepura - Grant number RC/URG/MED/2024/53
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-06-19
Approval number
20/24
Details of Ethics Review Committee
| Name: | University of Sri Jayewardenepura |
| Institutional Address: | Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Telephone: | 0718021350 |
| Email: | nilanka@sjp.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Nilanka Perera
Senior Lecturer
Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
+94112758000 (4300)
+94718021350
nilanka@sjp.ac.lk
Contact Person for Public Queries
Dr Nilanka Perera
Senior Lecturer
Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
+94112758000 (4300)
+94718021350
nilanka@sjp.ac.lk
Primary study sponsor/organization
University of Sri Jayewardenepura
Gangodawila, Nugegoda, Sri Lanka
+94 11 2881788
fms@sjp.ac.lk
https://medical.sjp.ac.lk/contact-us/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
IPD relevant to results will be uploaded after de identification to the following IPD database. Study protocol, statistical analysis plan, analytic code will also be available. https://vivli.org/ Data will be available immediately following publication, no end date. Anyone can access the data from the database for meta-analysis as specified by the investigators and this request will be processed by the IPD database review panel.
Study protocol available
Yes
Protocol version and date
Not published yet
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
