Condition category
Circulatory System
Date applied
26/09/2006
Date assigned
03/01/2007
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karoly Gombocz

ORCID ID

Contact details

Hajnal u. 19.
Zalaegerszeg
8991
Hungary
gomboczk@freemail.hu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DISIR

Study hypothesis

Cardiac surgery on CardioPulmonary Bypass (CPB) results in a complex immune response which is characterised by the activation of all inflammatory pathways and is strongly related to increased postoperative morbidity and mortality.

Animal experiments have confirmed that haemodilution with dextran decreases the endothelial adhesion of neutrophils in the post-ischaemic phase. However there are no exact clinical data in the literature that would support the anti-inflammatory effect of dextran infusion following cardiac surgery. Our hypothesis is that dextran inhibits the inflammatory mediator cascades after cardiac operations and diminishes ischaemia-reperfusion injury.

Ethics approval

Ethics approval gained from the Local Ethical Committee of Zala County Hospital on the 2nd February 2001.

Study design

Prospective, randomised, double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Myocardial ischaemia-reperfusion injury

Intervention

Two groups were formed following computerised randomisation. Twenty patients were given dextran-70 (6%) infusion (Macrodex, Pharmalink, Inc., Upplands Vasby, Sweden) (group A), whilst in the control group 20 patients were given oxypolygelatin (5.5%) infusion (Gelifundol, Biotest Pharma, Inc., Dreieich, Germany) (group B).

Following the induction of anaesthesia, artificial colloid was administered using infusion pumps (Model 591, IVAC, Inc., San Diego, USA). After the application of hapten inhibition by 20 ml dextran-1 (Promit, Fresenius Kabi, Inc., Norge AS, Norway), dextran-70 infusion was used in the dose of 7.5 ml/kg before CPB, and 12.5 ml/kg for 14 hours following the cessation of CPB. Gelatin was infused by the same body-weight based volume as dextran.

Arterial blood samples were obtained at six time points: before the operation (t0), ten minutes (t1), two hours (t2), four hours (t3), 24 hours (t4) and 44 hours (t5) after the cessation of CPB.

Intervention type

Drug

Phase

Not Specified

Drug names

Dextran, oxypolygelatin

Primary outcome measures

We have investigated the inflammatory mediator response determing the plasma concentration of some inflammatory mediators (procalcitonin, C-reactive protein, interleukin 6, interleukin 6r, interleukin 8, interleukin 10, macrophage migration inhibitory factor, soluble endothelial leukocyte adhesion molecule-1, soluble intercellular adhesion molecule-1, vascular cell adhesion molecule-1) and those of the ischaemia-reperfusion (cardiac troponin-I) between the dextran treated and the control groups following cardiac surgery.

Secondary outcome measures

Cardiopulmonary bypass alters vasomotor regulation reducing the endothelium dependent relaxation. We have investigated the effect of dextran on the kinetics of the haemodynamic variables (heart rate, arterial blood pressure, cardiac index, stroke volume index, systemic vascular resistance index, intrathoracic blood volume index, extravascular lung water index).

Overall trial start date

26/05/2002

Overall trial end date

10/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

First time cardiac surgery on Cardiopulmonary Bypass (CPB) (Coronary Artery Bypass Graft [CABG] or aortic valve replacement)

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

40 (following pilot study)

Participant exclusion criteria

1. 'Redo' operation
2. Hepatic disease
3. Renal dysfunction
4. Immunological disease
5. Steroid treatment
5. Intake of aspirin or other cyclooxygenase-inhibitor within seven days prior to surgery
6. Known allergy to volume expanders used in the study

None of the patients received volatile anaesthetics, steroids or aprotinin and haemofiltration were not used either. No shed mediastinal blood was retransfused during the post-operative period.

Recruitment start date

26/05/2002

Recruitment end date

10/01/2004

Locations

Countries of recruitment

Hungary

Trial participating centre

Hajnal u. 19.
Zalaegerszeg
8991
Hungary

Sponsor information

Organisation

European Society of Anesthesiologists (ESA) (Belgium)

Sponsor details

24 Rue des Comediens
Brussels
B-1000
Belgium

Sponsor type

Research organisation

Website

http://www.euroanesthesia.org/

Funders

Funder type

Research organisation

Funder name

European Society of Anesthesiologists (ESA) (Belgium) - Clinical Research Grant award

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17697359

Publication citations

  1. Results

    Gombocz K, Beledi A, Alotti N, Kecskés G, Gábor V, Bogár L, Koszegi T, Garai J, Influence of dextran-70 on systemic inflammatory response and myocardial ischaemia-reperfusion following cardiac operations., Crit Care, 2007, 11, 4, R87, doi: 10.1186/cc6095.

Additional files

Editorial Notes