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Effect of therapeutic plasma exchange on pulmonary haemorrhagic syndrome due to leptospirosis; an open-labeled randomized clinical trial -

SLCTR Registration Number

SLCTR/2018/013


Date of Registration

09 May 2018

The date of last modification

May 10, 2018


View original TRDS



Application Summary


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 of Health Condition(s) Studied

Leptospirosis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1211-5706 T


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


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


Assignment

Parallel


Purpose

Treatment


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

  • Age 15 to 80 , with lung hemorrhages due to leptospirosis.

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

  • Chronic kidney disease Stages iii, iv, v
  • Chronic hepatitis and liver cirrhosis of any etiology (compensated or decompensated)
  • Clinically manifested chronic obstructive airway disease, bronchial asthma, lung fibrosis
  • Pregnant women
  • Patients aged <15 and > 80 years
  • Patients who are haemodynamically unstable for TPE will also be excluded from the study.


Primary outcome(s)

Overall survival


Primary outcome(s) - Time of assessment(s)

During the hospital stay and at the time of discharge from the hospital


Secondary outcome

  • Duration of the ICU stay and hospital stay,
  • Need of ventilatory support
  • Need of inotrophs to support blood pressure,
  • Use of antiarrhythmic agents
  • Use of renal replacement therapy
  • Use of liver failure therapy
  • Incidence of sepsis
  • Incidence of pneumonia
  • Incidence of line infection spontaneous bleeding

Secondary outcome(s) - Time of assessment(s)

  • Duration of the ICU stay and hospital stay,
  • Need of ventilatory support
  • Need of inotrophs to support blood pressure,
  • Use of antiarrhythmic agents
  • Use of renal replacement therapy
  • Use of liver failure therapy
  • Incidence of sepsis
  • Incidence of pneumonia
  • Incidence of line infection spontaneous bleeding


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


Recruitment status

Pending


State of ethics review approval

Obtained


Funding source

None



Contact & Sponsor Information


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