The impact of continuous haemofiltration during cardiopulmonary bypass on cardiac surgery patients with impaired renal function

ISRCTN	ISRCTN48429978
DOI	https://doi.org/10.1186/ISRCTN48429978
Protocol serial number	704
Sponsor	Liverpool Heart and Chest Hospital NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - DH CSO Healthcare Scientist Research Fellowship

Submission date: 07/05/2009
Registration date: 15/07/2009
Last edited: 04/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bashir Matata
Scientific

Liverpool Heart and Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Email	bashir.matata@lhch.nhs.uk

Study information

Primary study design	Interventional
Study design	Pilot single-blind randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	HAEMOTRACKER-TRIAL
Study objectives	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(s)	Liverpool Heart and Chest Hospital, Medical Reseach Ethics Committee (MREC), 31/12/2009, ref: 09/H1005/71
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	196
Total final enrolment	199
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	01/03/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Liverpool Heart and Chest Hospital

Liverpool
L14 3PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2015	04/11/2019	Yes	No
Other publications	post-hoc analysis of biomarker levels	01/10/2019	04/11/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
02/10/2017: No publications found, verifying study status with principal investigator.