Contact information
Type
Scientific
Primary contact
Dr Bashir Matata
ORCID ID
Contact details
Liverpool Heart and Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom
-
bashir.matata@lhch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
704
Study information
Scientific title
The impact of intra-operative haemofiltration during on-pump cardiac surgery on biomarkers of oxidative stress and healthcare outcomes of patients with impaired renal function: a pilot randomised trial
Acronym
HAEMOTRACKER-TRIAL
Study hypothesis
The application of haemofiltration during cardiopulmonary bypass (CPB) reduces time to tracheal extubation, length of mechanical ventilation and attenuates post-operative anaemia, thrombocytopenia, hypoalbuminemia, post-operative bleeding and post-operative pulmonary complications and this would be the basis for a reduction in intensive care unit (ICU) stay, peri-operative complications and overall length of hospital stay in patients with impaired kidney function undergoing cardiac operations.
Ethics approval
Liverpool Heart and Chest Hospital, Medical Reseach Ethics Committee (MREC), 31/12/2009, ref: 09/H1005/71
Study design
Pilot single-blind randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pre-operative renal impairment/coronary heart disease/coronary heart interventions
Intervention
Current information as of 26/03/10:
Eligible patients will be randomised to one of the following groups:
1. Control group: ON-pump high risk cardiac (coronary artery bypass graft (CABG) alone, valve surgery, CABG plus valve) surgery patients with GFR <50 ml/min without haemofiltration
2. Experimental group: ON-pump high risk cardiac (coronary artery bypass graft (CABG) alone, valve surgery, CABG plus valve) patients with GFR <50 ml/min undergoing haemofiltration
Study timetable:
Start of recruitment: April 2010 - Mar 2013
End of follow-up: Apr 2013
Analysis and reporting: May 2013 - Jul 2013
Final report: Sep 2013
Initial information at time of registration:
Patients that fulfil inclusion and exclusion criteria will be asked to give consent for the study and will be randomised into the two study groups by a computer-generated programme:
1. ON-pump isolated CABG patients with GFR less than 60 ml/min without haemofiltration (control arm)
2. ON-pump isolated CABG patients with GFR less than 60 ml/min undergoing haemofiltration
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Current information as of 26/03/10:
Length of ICU stay for non-dialysis patients with impaired kidney function (estimated glomerular filtration rate <50 ml/min)
Initial information at time of registration:
Incidents of ICU stay greater than 3 days for patients with eGFR less than 60 ml/min.
Secondary outcome measures
Current information as of 26/03/10:
1. Clinical Outcomes
1.1. Duration of Hospital stay
1.2. Myocardial infarction
1.3. The mean eGFR/creatinine clearance values at hospital discharge
2. Biomarkers Outcomes:
2.1. Plasma levels of protein nitration
2.2. 8-isoprostanes
2.3. Malondialdehyde levels
2.4. Plasma and erythrocyte reduced/oxidised glutathione (GSH/GSSG) ratio
2.5. Urinary N-acetyl-D-glucosamine (D-NAG) excretion
2.6. Highly sensitive C-reactive protein (hsCRP)
2.7. Tumour necrosis factor alpha (TNF-α)
Measured at baseline, during CPB, 24 hours and 48 hours after the operation.
3. Secondary Economic Outcomes:
Resource utilisation and key costs indicators associated with each of the two pilot arms estimated up until hospital discharge. Specifically:
3.1. ICU stay and hospital stay
3.2. Postoperative renal replacement therapy
3.3. Mechanical ventilation
3.4. Medications
Initial information at time of registration:
1. Clinical outcomes:
1.1. Overall length of hospital stay
1.2. Need for renal support post-operatively
1.3. Mechanical ventilation time
1.4. Length of tracheal intubation
1.5. Arrhythmias
1.6. The worst eGFR/creatinine clearance values during hospital stay
1.7. Myocardial infarction
2. Biomarker outcomes:
Markers of oxidative stress and the systemic inflammatory response.
3. Cost outcomes:
Resource utilisation and costs associated with the intra-operative haemofiltration, care at the ICU and ward and adverse events (e.g., bleeding complications, sepsis), requirement for post-operative haemofiltration will be measured. Since the number of operations performed in most cardiac centres depend on availability of ICU beds, the implications for the productivity of the ICU unit will be explored by simulating its activity and resource flows and outcomes, in terms of operations performed per unit time (e.g., a year).
Patients will be followed-up for all secondary outcome measures until the time of hospital discharge.
Overall trial start date
01/08/2009
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current information as of 26/03/10:
1. Consenting men and women aged at least 18 years old
2. High-risk patients elective for on-pump valve replacement, coronary artery bypass graft surgery (CABG) or combined CABG and valve procedures
3. Patients with impaired renal function established preoperative by an estimated glomerular filtration rate (eGFR) <50 ml/min
Initial information at time of registration:
1. Male and female patients, at least 18 years old
2. Elective for on-pump coronary artery bypass graft surgery (CABG)
3. Patients with impaired renal function established by pre-operative estimated glomerular filtration rate (eGFR) less than 60 ml/min
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
196 (as of 26/03/2010; previous sample size: 60)
Participant exclusion criteria
Current information as of 26/03/10:
1. Patients scheduled to undergoing cardiac surgery with anticipated CPB time <60 minutes
2. Patients undergoing surgery on the great vessels (aortic surgery)
3. Patients with significant impaired liver function (serum bilirubin > 60 or INR >2 without anticoagulation)
4. Patients who are further down the line of renal failure (i.e. eGFR <15 ml/min)
5. Patients on-dialysis
6. Presence of malignancy
7. Pregnancy
Initial information at time of registration:
1. Undergoing valve replacement surgery
2. Patients with significant impaired liver function (serum bilirubin greater than 60 or international normalised ratio [INR] greater than 2 without anticoagulation)
3. Patients on-dialysis
4. Patients that are pregnant or have malignancy
Recruitment start date
01/04/2010
Recruitment end date
01/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Heart and Chest Hospital
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Liverpool Heart and Chest Hospital NHS Trust (UK)
Sponsor details
Thomas Drive
Liverpool
L14 3PE
United Kingdom
-
mark.jackson@lhch.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - DH CSO Healthcare Scientist Research Fellowship
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