Early Haemadsorption in Major Burns

NCT04195126 | Unknown

• 1 other identifier: 7066 - PTE 2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 7 days mortality

  The investigators assess the intensive care and post-intensive care mortality of our patients.

  Survival rate is assessed in the 7th admission day.

• 28 days mortality

  The investigators assess the intensive care and post-intensive care mortality of our patients.

  Survival rate is assessed in the 28th admission day.

Secondary Outcomes (7)

• Levels of inflammatory and anti-inflammatory cytokines during treatment

  Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot. Data will be presented in arbitrary units.

• Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)

  Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot.

• Intensive Care Unit length of stay

  Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.

• Volume resuscitation fluid need of our patients.

  Results are summarised daily for our patients during the first week following inclusion.

• Vasopressor need of our patients.

  Results are summarised daily for our patients during the first week following inclusion.

Study Arms (2)

Control group

NO INTERVENTION

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.

Treatment group

ACTIVE COMPARATOR

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

Device: CytoSorb haemadsorption device

Interventions

CytoSorb haemadsorption device 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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs, Dept. of Anaesthesia and Intensive Care

Pécs, Baranya, 7622, Hungary

Location

MeSH Terms

Conditions

Burns; Multiple Organ Failure; Shock; Renal Insufficiency; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Gábor Woth, MD PhD

  University of Pécs, Dept. of Anaesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gábor Woth, MD PhD

CONTACT

+36703729231; glwoth@gmail.com

Tamás Kiss, MD PhD

CONTACT

kisstamasmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients included in our study are randomised into treatment or control groups.

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: December 11, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

HU (1)