Transplant Trial Watch

Daily Ciprofloxacin Treatment for Patients with Advanced Liver Disease Awaiting Liver Transplantation Reduces Hospitalizations.

Minuk GY, Hawkins K, et al.

Digestive Diseases & Sciences, 56(4): 1235-41, 2011.


Aims
To determine whether daily ciprofloxacin therapy would improve liver function and result in fewer hospitalizations in patients with advanced liver disease awaiting liver transplantation.

Interventions
Oral ciprofloxacin at a dose of 250mg (<75 kg weight) or 500 mg (>75 kg weight), versus placebo twice daily for 1 or 3 months.

Participants
44 patients with advanced liver disease awaiting liver transplantation.

Outcomes
The primary endpoint was liver function measured as albumin, international normalized ratio of prothrombin and bilirubin at 1 month. The secondary endpoint was hospitalizations after 3 months of therapy. Other laboratory parameters included haemoglobin, white blood cell count, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatise, gamma glutamyltransferase.

Follow-up
3 months

CET Conclusions
In patients with advanced liver disease awaiting transplantation, the administration of oral ciprofloxacin in comparison with a placebo for either one or three months before transplantation, did possibly result in less hospitalisation but did not demonstrate any improvement in liver function.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
Yes

Quality notes
This is a sub-analysis of a previous publication of the same RCT: Potena L, Bianchi IG, Magnani G, et al. Cyclosporine lowering with everolimus or mycophenolate to preserve renal function in heart recipients: a randomized study. Transplantation 2010;89:263-5. The methodological quality assessment was based on the previous publication.

Trial registration
Not reported

Funding source
Non-industry funded