Influence of Dextran-70 on Systemic Inflammatory Response and myocardial ischaemia-reperfusion following cardiac operations

ISRCTN ISRCTN38289094
DOI https://doi.org/10.1186/ISRCTN38289094
Secondary identifying numbers N/A
Submission date
26/09/2006
Registration date
03/01/2007
Last edited
30/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Karoly Gombocz
Scientific

Hajnal u. 19.
Zalaegerszeg
8991
Hungary

Email gomboczk@freemail.hu

Study information

Study designProspective, randomised, double blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDISIR
Study objectivesCardiac 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(s)Ethics approval gained from the Local Ethical Committee of Zala County Hospital on the 2nd February 2001.
Health condition(s) or problem(s) studiedMyocardial ischaemia-reperfusion injury
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dextran, oxypolygelatin
Primary outcome measureWe 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 measuresCardiopulmonary 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 study start date26/05/2002
Completion date10/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants40 (following pilot study)
Key inclusion criteriaFirst time cardiac surgery on Cardiopulmonary Bypass (CPB) (Coronary Artery Bypass Graft [CABG] or aortic valve replacement)
Key exclusion criteria1. '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.
Date of first enrolment26/05/2002
Date of final enrolment10/01/2004

Locations

Countries of recruitment

  • Hungary

Study participating centre

Hajnal u. 19.
Zalaegerszeg
8991
Hungary

Sponsor information

European Society of Anesthesiologists (ESA) (Belgium)
Research organisation

24 Rue des Comediens
Brussels
B-1000
Belgium

Website http://www.euroanesthesia.org/
ROR logo "ROR" https://ror.org/0102p7z54

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2007 Yes No