Role of oral Midodrine in preventing hepatorenal syndrome in Child-Turcotte-Pugh class C cirrhotics: a pilot study.

AIM: The purpose of the study was to assess benefits of oral midodrine in the role of primary prevention of hepatorenal syndrome (HRS) in Child-Turcotte-Pugh Class C (CTP-C) cirrhotics.

BACKGROUND

The present non-randomized pilot study was designed for primary prevention of HRS as there is absence of an effective and definite treatment for this complication of cirrhosis to date other than liver transplant (LT).

METHODS

This study effectively involved 30 patients each enrolled in interventional and control arms suffering from liver cirrhosis CTP-C with normal renal function and having a mean arterial pressure (MAP) < 80 mmHg who were subjected to clinical examination and baseline blood investigations. The mean daily dosage of midodrine used across the study group was 16.75 mg.

RESULTS

At the end of 4 months of study, 11 individuals completed the study without attaining any endpoints from the control group while 23 accomplished it from the interventional arm. Nearly 50 % patients required a midodrine dose of 7.5 mg 8th hourly while the rest attained the targeted MAP with lower doses. By increasing MAP, the rate of HRS development during the study period (i.e. 4 months) was found to be significantly reduced in patients from interventional arm. The number needed to treat (NNT) observed in survival analysis to prevent one death was found to be 7.6.

CONCLUSION

This study successfully established the role oral midodrine in primary prevention of HRS in cirrhotics at high risk. Midodrine was well tolerated with no significant adverse effects in patients under study.