Condition category
Urological and Genital Diseases
Date applied
26/03/2010
Date assigned
06/07/2010
Last edited
07/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is estimated that up to 20 in 100 patients undergoing cardiac (heart) surgery have a pre-existing kidney impairment that is associated with an increased risk of death during or after the operation. Earlier studies have demonstrated that applying blood filtration (haemofiltration) within the first 48 hours after the operation halves the risk of death. The performance of the procedure two days after surgery may be too late to protect the patient's kidneys from further injury. The aim of this study is to investigate whether haemofiltration performed at the point when the patient is connected to the heart and lung bypass machine during surgery may be more beneficial.

Who can participate?
Patients aged 18 or over, undergoing on-pump coronary artery bypass graft surgery, and who have impaired kidney function.

What does the study involve?
Participants are randomly allocated into two groups. The control group undergo on-pump coronary artery bypass graft surgery without haemofiltration. The intervention group undergo on-pump coronary artery bypass graft surgery with haemofiltration. Participants are followed after the operation to determine their kidney function and length of ICU stay.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Liverpool Heart & Chest Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
July 2010 to July 2011

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Bashir Matata
bashir.matata@lhch.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bashir Matata

ORCID ID

Contact details

Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 6001380
bashir.matata@lhch.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/53/33; 853

Study information

Scientific title

The impact of continuous haemofiltration with high volume fluid exchange during cardiopulmonary bypass surgery on the recovery of patients with impaired renal function - a pilot study

Acronym

FOBS (Filtration on Bypass Surgery)

Study hypothesis

We hypothesise that intraoperative haemofiltration significantly reduces incidences of intensive care unit stay longer than 3 days for patient with preoperative impaired kidney undergoing coronary artery bypass graft surgery.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/085333
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/53002/PRO-08-53-33.pdf

Ethics approval

Liverpool Heart and Chest Hospital, Medical Research Ethics Committee (MREC), 09/06/2010

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

Preoperative renal impairment; coronary heart disease; cardiac artery bypass graft surgery

Intervention

Patients that fulfil inclusion and exclusion criteria will be fully informed about the study and asked to give consent for the study. They will be randomised into two study groups by a computer-generated programme:
1. Control group: Patients with estimated GFR <60 ml/min undergoing ON-pump coronary artery bypass graft surgery without intraoperative haemofiltration
2. Intervention group: Patients with estimated GFR <60 ml/min undergoing ON-pump coronary artery bypass graft surgery with intraoperative haemofiltration

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Incidents of ICU stay >3 days for patients with renal impairment identified as an estimated glomerular filtration (eGFR) <60 ml/min

Secondary outcome measures

1. Clinical outcomes:
1.1. Composite of perioperative incidences:
1.1.1. Bleeding
1.1.2. Sepsis
1.1.3. Death
1.1.4. Arrhythmias
1.1.5. Stroke
1.1.6. Myocardial infarction
1.2. Need for postoperative continuous veno-venous haemofiltration (CVVH) in the ICU and wards - Indications for requirement of postoperative continuous veno-venous haemofiltration must adhere to our strict NHS Trust criteria and guidelines.
1.3. Mechanical ventilation time
1.4. Hospital stay
1.5. eGFR at 6 weeks follow-up
2. Economic outcomes: Resource utilisation and costs associated with each of the two pilot arms such as:
2.1. ICU stay and hospital stay
2.2. Mechanical ventilation
2.3. Medications
2.4. Tests and procedures undertaken until the end of the follow-up period

Overall trial start date

01/07/2010

Overall trial end date

30/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consenting men and women must be at least 18 years old
2. High-risk patients elective for on-pump coronary artery bypass graft surgery (CABG)
3. Impaired renal function established preoperatively by an estimated glomerular filtration rate (eGFR) <60 ml/min measured within 4 weeks before surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients undergoing surgery on the great vessels (aortic surgery)
2. Patients with significantly impaired liver function (serum bilirubin> 60 or INR>2 without anticoagulation)
3. Patients who are further down the line of renal failure or on-dialysis
4. Patients with malignancy
5. Those that are pregnant

Recruitment start date

01/07/2010

Recruitment end date

30/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital
Liverpool
L14 3PE
United Kingdom

Sponsor information

Organisation

Liverpool Heart & Chest Hospital NHS Foundation Trust (UK)

Sponsor details

Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 2281616
mark.jackson@lhch.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.lhch.nhs.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24176099

Publication citations

  1. Results

    Matata B, Mediratta N, Morgan M, Shirley S, Scawn N, Kemp I, Stables R, Haycox A, Houten R, Richards S, McLeod C, Lane S, Sharma A, Wilson K, The impact of continuous haemofiltration with high-volume fluid exchange during cardiopulmonary bypass surgery on the recovery of patients with impaired renal function: a pilot randomised trial., Health Technol Assess, 2013, 17, 49, i-xiv, 1-84, doi: 10.3310/hta17490.

Additional files

Editorial Notes

07/06/2016: Plain English summary added.