Condition category
Urological and Genital Diseases
Date applied
07/05/2009
Date assigned
15/07/2009
Last edited
26/05/2015
Prospective/Retrospective
Prospectively 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 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

We hypothesise that 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.

Please note that as of 26/03/2010 this record has been extensively updated. All updates can be found in the relevant field with the above update date.

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 below 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 measures

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

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

http://www.lhch.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes