Home » Trials » SLCTR/2018/013
Effect of therapeutic plasma exchange on pulmonary haemorrhagic syndrome due to leptospirosis; an open-labeled randomized clinical trial
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SLCTR Registration Number
SLCTR/2018/013
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of therapeutic plasma exchange on pulmonary haemorrhagic syndrome due to leptospirosis; an open-labeled randomized clinical trial
Public Title of Trial
Plasma exchange for lung haemorrhages in leptospirosis
Disease or Health Condition(s) Studied
Leptospirosis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1211-5706 T
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
How effective is therapeutic plasma exchange (TPE) in reducing mortality and morbidity in patients with pulmonary hemorrhages due to leptospirosis?
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 3
Intervention(s) planned
Study setting: Medical wards, emergency care unit and intensive care units of the Teaching Hospital, Karapitiya
Randomisation: patients will be allocated to two arms using the Block randomization (Blocks of two) method.
Intervention: A femoral line will be inserted for vascular access and Acid Citrate Dextrose (ACD) will be used as the anticoagulant of choice. ACD to whole blood ratio of 1:12 to 1: 14 will be maintained.
The speed set for blood pump will be 50 ml per minute initially as most of these patients are hypotensive and on inotropes and then gradually increased to 80 ml depending on the patient’s haemodynamic stability. Return speed will also be kept at 80 ml/min to prevent entering of high citrate load rapidly.
Patient’s height, weight and haemotocrit will be entered to machine and the machine automatically calculates the patient’s blood volume and plasma volume. One plasma volume will be exchanged with Fresh Frozen Plasma (FFP). Percentage of replacement will be kept around 90 – 95% as most of these patients have acute kidney injury with low urine output. Mean number of cycles are three and done on three consecutive days.
Blinding - This is an open-labeled study
Inclusion criteria
Diagnosis of leptospirosis: Patients with a clinical picture suggestive of leptospirosis and confirmed with PCR, MAT or both)
Definition of leptospirosis associated pulmonary hemorrhage: Patient with confirmed leptospirosis presenting with haemoptysis, arterial hypoxemia (Acute Lung Score < 2.5), haemoglobin drop (>10% from the previous value), or diffused alveolar shadows in the chest radiograph. The above manifestations should not have an alternative explanation.
Exclusion criteria
Primary outcome(s)
|
1.
Overall survival |
[ During the hospital stay and at the time of discharge from the hospital ] |
Secondary outcome(s)
|
1.
Duration of the ICU stay and hospital stay |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
2.
Need of ventilatory support |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
3.
Need of inotrophs to support blood pressure |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
4.
Use of antiarrhythmic agents |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
5.
Use of renal replacement therapy |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
6.
Use of liver failure therapy |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
7.
Incidence of sepsis |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
8.
Incidence of pneumonia |
[ During the hospital stay and at the time of discharge from the hospital ] |
|
9.
Incidence of line infection spontaneous bleeding |
[ During the hospital stay and at the time of discharge from the hospital ] |
Target number/sample size
32 (16 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-06-01
Anticipated end date
2019-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-03-22
Approval number
15.02.2018: 3.15
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof Sarath Lekamwasam
Professor of Medicine
Department of Medicine
Faculty of Medicine
Galle
091234730
0777275360
slekamwasam@gmail.com
Contact Person for Public Queries
Prof Sarath Lekamwasam
Professor of Medicine
Department of Medicine
Faculty of Medicine
Galle
091234730
0777275360
slekamwasam@gmail.com
Primary study sponsor/organization
Dr Nalaka Herath
Consultant Nephrologist
Teaching Hospital
Karapitiya
GAlle
0718133369
nalakajeewa@gmail.com
Secondary study sponsor (If any)
Dr Wimalasiri Uluwatta
Consultant Physician
Teaching Hospital
Karapitiya
GAlle
uwimalasiri@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
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
