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Early Haemadsorption in Major Burns

NCT ID: NCT04195126

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-07-01

Brief Summary

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Major deep burns (\>20% body surface, involving deep skin layers) and associated severe inflammatory reaction and their complication are one of the biggest challenge of intensive care. Haemoadsorption therapy, including the CytoSorb treatment is a promising novel therapeutic approach, but only case-studies are available in the literature yet. Based on data from septic shock patient treatment the investigators hypothesize that CytoSorb is beneficial in early treatment of burns. The investigators aim to conduct a randomised-controlled study to assess the clinical effectiveness (based on score systems including MODS, SOFA, APACHE II, KDIGO, ABSI), 7 and 28 days survival, intensive care length of stay, length of mechanical ventilation, resuscitation fluid need and ino/vasopressor drug doses and the presence and severity of organ dysfunctions, particularly renal dysfunction. The investigatora plan to conduct basic research to elucidate the pathophysiological background of clinical effect, including the measurement of inflammatory and anti-inflammatory cytokines, presence and severity of oxidative stress (lipid peroxidation, protein oxidation, reduced/oxidised glutathion levels) and organ dysfunction markers (kidney injury molecule -1, neutrophil gelatinase-associated lipocalin, cystatin-C, uromodulin).

Detailed Description

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Conditions

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Burns Multiple Organ Failure Shock Organ Dysfunction Syndrome, Multiple Renal Dysfunction Cytokine Storm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients included in our study are randomised into treatment or control groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.

Study Groups

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Control group

Patients are treated according to most recent guidelines in burn trauma and corresponding emergency and intensive therapy. All patients included are treated with early continous veno-venal renal replacement therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment group

Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).

Group Type ACTIVE_COMPARATOR

CytoSorb haemadsorption device

Intervention Type DEVICE

CytoSorb (Cytosorbents Inc.) aspecific blood purification device used in an extracorporeal circulation system without dialysis column. Anticoagulation is managed by siodium citrate-Calcium system, using the Gambro CVVHDF capable device.

Interventions

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CytoSorb haemadsorption device

CytoSorb (Cytosorbents Inc.) aspecific blood purification device used in an extracorporeal circulation system without dialysis column. Anticoagulation is managed by siodium citrate-Calcium system, using the Gambro CVVHDF capable device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* informed consent of our patient or next of kin,
* TBSA \>20% with 2/b depth of burn

Exclusion Criteria

* non-thermal burn injury,
* need for acute haemodialysis (intoxication),
* immunosuppressive treatment, chronic steroid use (\> 3 months),
* known malignant disease,
* end-stage renal insufficiency or renal transplantation,
* Child C hepatic cirrhosis,
* gravidity,
* potentially lethal burn (Baux index \>120) or comorbidities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gábor Woth, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pécs, Dept. of Anaesthesia and Intensive Care

Locations

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University of Pécs, Dept. of Anaesthesia and Intensive Care

Pécs, Baranya, Hungary

Site Status

Countries

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Hungary

Central Contacts

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Gábor Woth, MD PhD

Role: CONTACT

Phone: +36703729231

Email: [email protected]

Tamás Kiss, MD PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Gábor Woth, MD PhD

Role: primary

Tamás Kiss, MD PHD

Role: backup

Other Identifiers

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7066 - PTE 2018

Identifier Type: -

Identifier Source: org_study_id