Condition category
Digestive System
Date applied
05/09/2012
Date assigned
13/11/2012
Last edited
13/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dieter Falkenhagen

ORCID ID

Contact details

Danube University Krems
Dr. Karl Dorrek Str. 30
Krems
3500
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CIP V1.0

Study information

Scientific title

Product safety study for a citrate calcium anti-coagulation system and its application for liver insufficiency

Acronym

Study hypothesis

Specification of a target calcium value in the anticoagulated extracorporeal circuit is associated with a high functionality and high safety using a citrate calcium anticoagulation.

The aim is to gain proof of functionality and safety of an algorithm for automated software controlled regional citrate-calcium anticoagulation applied to patients with liver insufficiency.

Ethics approval

Medical University Graz Ethics Committee, Austria

Study design

Interventional single-arm open-label trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet [German]

Condition

Liver insufficiency

Intervention

Regional anticoagulation with trinatrium citrate and substitution with calcium chloride. Two treatments per patient, with a duration of 6 hours per treatment planned.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 6 hours):
1. Evaluation of the ionized calcium level in the extracorporeal circuit
2. Evaluation of the ionized calcium level in the patient

Secondary outcome measures

The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 6 hours):
1. Citrate
2. iMg
3. Total Mg
4. Total calcium
5. Activated clotting time (ACT)

The following will be assessed at baseline and end of each treatment period:
1. Blood count
2. Albumin
3. Total protein

Overall trial start date

01/01/2013

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females with age: 18-75 years
2. Serum Bilirubin > 5 mg/dL (more than 72 h)
3. Model for End Stage Liver Disease (MELD) > 30 (more than 72 h) or
4. Therapeutic resistant hepatic encephalopathy ≥ II° or
5. Therapeutic resistant kidney failure (requiring dialysis) or
6. Therapeutic resistant alcoholic hepatitis or
7. Therapeutic resistant pruritus [Visual Analogue Scale (VAS) > 7]

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. INR > 3
2. Thrombocytes < 30,000
3. Multiorgan failure (liver and > 3 organs)
4. M ean arterial pressure (MAP) < 55 mmHg
5. Acute bleeding (>4 Erythrocyte concentrates in the last 24 hours)
6. Extra hepatic cholestasis

Therapeutic resistance:
1. Hepatic Encephalopathy: Lactulose 60g/d and Ornithin-Aspartate 20g/d i.v. within 72h
2. Kidney failure: volume support albumin 1g/kg-KG, Terlipressin (3 mg/d) within 72h
3. Alcoholic hepatitis: Prednislon 40 mg within 7 days and Lille Score >0.45
4. Pruritus: Cholestyramin 8g and Naltrexone 50 mg within 4 weeks

Recruitment start date

01/01/2013

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Austria

Trial participating centre

Danube University Krems
Krems
3500
Austria

Sponsor information

Organisation

Danube University Krems (Austria)

Sponsor details

Dr. Karl Dorrek Str. 30
Krems
3500
Austria

Sponsor type

University/education

Website

http://www.donau-uni.ac.at/

Funders

Funder type

University/education

Funder name

Danube University Krems (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes