None listed
Conditions
Brief summary
Contrast-induced nephropathy is a relatively common complication for chronic kidney disease patients who are undergoing a procedure involving contrast dye, such as a coronary angiogram, affecting around 15% of patients in this population. This condition is characterised by kidney damage that occurs a short time, usually within three days, after having the contrast procedure. We know when a patient experiences contrast-induced nephropathy by observing the levels of creatinine, an enzyme produced by the kidney, in the blood. Creatinine levels are observable from a blood test. Rates of contrast-induced nephropathy can likely be reduced using hydration and forced diuresis (increased urine output using medication). Currently, we try to reduce the incidence of contrast-induced nephropathy by hydrating patients with intravenous saline before and after the angiogram. However, it may be possible to reduce the rates of contrast-induced nephropathy even further by implementing a new regime of hydration and forced diuresis. This research project aims to identify a new, effective method of reducing rates of contrast-induced nephropathy in patients with advanced stage III, IV and V chronic kidney disease who are having a coronary angiogram at the Lyell McEwin Hospital. Patients who consent to participate in this research project will be randomly sorted in one of two groups: the control group (patients who will receive the current usual standard of care, which involves receiving saline through an intravenous drip) and the experimental group (patients who will receive a dose of furosemide for forced diuresis and euvolemic fluid replacement). Participants will not be randomised into a group until they have provided written informed consent agreeing to participate. The primary outcome for this study is development of contrast-induced nephropathy. The secondary outcomes is length of hospitalisation.
Interventions
Prevention of contrast-induced nephropathy by combined induced diuresis with euvolemic fluid resuscitation.
All eligible participants will be approached by one of the study doctors to discuss their participation in the trial. They will be approached at their cardiology appointment or at the time their coronary angiogram is scheduled. At this time, they will be given a Participant Information Sheet and Consent Form, and all aspects of this document will be explained by the study doctor. Upon agr
Prevention of contrast-induced nephropathy by combined induced diuresis with euvolemic fluid resuscitation. All eligible participants will be approached by one of the study doctors to discuss their participation in the trial. They will be approached at their cardiology appointment or at the time their coronary angiogram is scheduled. At this time, they will be given a Participant Information Sheet and Consent Form, and all aspects of this document will be explained by the study doctor. Upon agreeing to participate in the trial, the participants are randomised on a 1:1 basis into either the control group or the experimental group. The trial is being conducted at the Lyell McEwin Hospital, an acute tertiary care centre in the northern metropolitan suburbs of Adelaide. Every participant will be undergoing a coronary angiogram as a part of their care. The interventionalist performing their angiogram will be one of the study doctors. Once the participant has been randomised to one of the study groups, the study doctor will give instructions to the medical and nursing staff of the care and treatment that the participant will have. The study doctors are ultimately responsible for ensuring that the protocol is followed. The study doctors, PIs Pati and Arstall, and AI Mugwagwa, will prescribe the intervention or control treatment. Ward nursing staff will be responsible for continuing the administration of the treatment for the prescribed amount of time. Nursing staff will administer the medication for the intervention group as per the study doctors' instructions. Dr Purendra Pati is the principal investigator for this trial. He is a consultant cardiology interventionalist and is coordinator of the cath-lab at the Lyell McEwin Hospital. He has extensive experience in managing patients with chronic kidney disease undergoing a coronary angiogram. A/Prof Margaret Arstall is also a principal investigator on this trial. She is the Director of Cardiology at the Northern Adelaide Local Health Network and has extensive experience as a consultant cardiologist and in research endeavours. Dr Augustine Mugwagwa is an associate investigator and study doctor on this trial. He is a cardiology advanced trainee and works under the direction and supervision of Dr Pati. Dr Nitesh Rao is also an associate investigator and study doctor on this trial. He is a consultant nephrologist who will provide expert advice to the other members of the study team in relation to kidney disease. Emily Aldridge is an associate investigator and study coordinator of this trial. She is a clinical researcher and is responsible for randomisation and data management. The intervention is induced diuresis via furosemide and euvolemic fluid resuscitation. Participants in the intervention group will receive a dose of 0.5 mg/kg body weight of intravenous furosemide after a 250 ml bolus of normal saline. Urine output is measured hourly. The amount of fluid lost through urine output is replaced with intravenous saline until an output of > 300 ml is attained. If the participant fails to reach an output of > 300 ml, a repeat dose of furosemide and saline will be given. The intervention occurs once only (unless a second dose is required as previously mentioned) and takes 1.5 - 3 hours. Once the desired output is reached, the study doctor performs the contrast procedure. After the procedure, the participant continues on matched hydration therapy for 12 hours. If the urine output falls below or fails to reach 150 ml/hr in the first four hours following the procedure, a repeat dose of furosemide will be given.
Sponsors
A/Prof Margaret Arstall
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for this trial include: 1. All adult patients with advanced stage III, IV or V chronic kidney disease (serum creatinine more than 1.6 mg/dl (145 mmol/L) and eGFR of less than 40ml/min/1.73m2, and/or Mehran's risk score of 6-16) undergoing an elective or urgent, diagnostic or therapeutic radiocontrast procedure will be approached for consent.
Exclusion criteria
Exclusion criteria for this trial include: 1. Patients with contrast allergy 2. Hypersensitivity to furosemide 3. Patient on maintenance haemodialysis or peritoneal dialysis 4. Radiocontrast procedure conducted within 72 hours 5. Contraindication or failure to pass urinary catheter 6. Patients with fluctuating baseline serum creatinine measurements 7. Patients with acute renal failure 8. Patients requiring emergency angiography procedures (e.g. STEMI cases)
Outcome results
None listed