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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17697359
Publication citations
-
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.