The ADEMEX Trial Adequacy of PD in Mexico Reference Paniagua R, et al. Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial. J Am Soc Nephrol. 2002;13:1307–1320.

Background In peritoneal dialysis (PD), small solutes clearance targets have often been established assuming that peritoneal and renal clearances are equivalent and consequently additive. There is a tremendous need to enhance the peritoneal clearance. This has led to increased cost, lowered quality of life and increased rates of withdrawal due to inability to meet targets, reluctance to initiate PD for large or anuric patients.

Aim To study the effects of increased, peritoneal clearances on mortality rates in peritoneal dialysis.

Method Study design: The ADEMEX trial was a prospective, randomized, controlled clinical trial. Study population: A total of 965 patients undergoing CAPD were enrolled in the study. Patients were screened with ERSD who were treated with PD at the centers. The patients were between 18 and 70 years of age were eligible if they were undergoing CAPD and showed measured peritoneal creatinine clearance (pCrCl) values of <60 L/week per 1.73 m irrespective of their renal function. Patients who were seropositive for hepatitis B or HIV, on immunosuppressive therapy, had malignant cancer or cardiac failure were excluded from the trial.

Treatment regimen: Patients were randomly assigned to the intervention or control group in a 1:1 ratio. The patients in the control group continued with their existing PD prescriptions (4 daily exchanges of 2 L of standard PD solution). The patients in the randomized intervention group were given a modified PD regimen to achieve the pCrCl value of 60 L/week per 1.73 m2. Two prescription changes were allowed to achieve the target for each patient. The first new prescription was based on the body size; patients with a body surface area of ≤1.78 m2 received a prescription of four exchanges of 2.5 L in 24 h and in patients with a body surface area >1.78 m2 got a prescription exchange of 3.0 L in 24 h. End point: Death was the primary end point for this study. Hospitalizations, therapy-related complications, correction of anemia, and effects on nutritional status were some of the secondary end points.

Result In both the groups around 40% of the patients reached or exceeded a total CrCl or 60 L/week per 1.73 m2 or a total Kt/V of 2.0. The incidences of ischemic heart disease were 4.3% in control and 3.1% in intervention group and stroke were 1.7% in control and 1.5% in the intervention group. A total of 157 deaths occurred in the control group as compared to 159 in the intervention group. Age, diabetes mellitus, serum albumin levels, residual renal functions and nPNA values were identified as factors associated with patient survival. These results were similar and indicate the success of randomization procedure.

Conclusion The ADEMEX trial is a pioneering study in the field of PD. The ADEMEX examines the effect of enhancement of peritoneal clearances on patient outcomes. It indicates that the survival benefit of PD is obtained within a range of clearances achievable in usual practice. The inability of a patient to achieve the target clearances defined by current clinical guidelines should not disqualify the patient from continuing to undergo PD if other aspects of patient case are satisfactorily addressed by PD. The ADEMEX trial is a pioneering study in the field of peritoneal dialysis (PD). It examines the effect of enhancement of peritoneal clearances on patient outcomes and survival benefit of PD is obtained within a range of clearances achievable in usual practice.