Background
Medical treatment of severe intermittent claudication or critical limb-threatening ischemia causing rest pain frequently achieves only partial relief or is not effective at all.
Methods
Patients with severe intermittent claudication or rest pain of the lower extremities who did not improve after control of risk factors, supervised exercises, and cilostazol medication were included in this study. All patients were treated with hydration. They were asked to drink 2500 mL of fluids (water, soup, milk) during a 24-hour period and to ingest 0.6 g/kg of albumin a day, as egg white or albumin powder. Total salt administered daily was 3.5 g. Symptoms, skin temperature, ankle-brachial index, albumin concentration in serum, and time and distance to claudication were recorded before treatment, at 6 weeks, and at 6 months. Electrolytes were measured monthly. No additional treatment was used during the study. Walking was encouraged but not supervised. The trial has continued indefinitely. For statistical analysis, SPSS software (IBM Corp, Armonk, NY) was used. The Ethical Committee approved the protocol, and an informed consent was signed by all patients.
Results
There were 132 patients (94 male, 38 female) included in the study. Median age was 72.5 years (range, 67-77 years); all had severe claudication of a mean of 100 meters or rest pain. Symptoms had been present for >5 months in all patients; 22 (16.8%) had rest pain. Proper hydration, determined as drinking at least 2000 mL of water during 24 hours for a period of 6 months, was achieved in 131 compliant patients. Only one patient failed to drink 2000 mL of water or more. Ankle-brachial index in 131 compliant patients improved from 0.6 to 0.75 (P < .0001) after 6 months. Skin temperature of the feet increased from 29.4°C to 31.7°C (P = .009). Distance to claudication using the treadmill improved from 100 meters to 535 meters (P < .0001) at 6 weeks and remained stable at 6 month in 65.83% of the patients; in 34.17% of them, distance to claudication increased further by 200 (100-500) meters and time to claudication improved from 1.3 to 6.3 minutes (P < .0001) at 6 weeks, but the same group of patients (34.17%) that increased the distance to claudication further prolonged the time to claudication by 2.49 (1.24-6.23) minutes. All 131 compliant patients improved their status related to lower extremity ischemia; the noncompliant patient did not have any variation of symptoms, skin temperature, ankle-brachial index, or time and distance to claudication. All patients survived the initial 6 months of treatment; afterward, three patients abandoned the treatment and four died of unrelated causes. After the 6-month control, 49% of the patients continued to improve the time and distance to claudication as well as the ankle-brachial index. The rest of the patients conserved the initial improvement. Five patients who had significantly improved the time and distance to claudication were asked to decrease water intake for 3 days. No changes in time and distance to claudication were detected. Hydration was reinitiated.
Conclusions
This study suggests that proper hydration by drinking ≥2000 mL of water daily and albumin complement orally to reach 4 g/dL in serum could be included in the armamentarium of physicians treating patients with disabling claudication or rest pain caused by peripheral artery disease. Further comparative studies to assess the benefit of hydration and increasing the serum oncotic pressure are warranted.
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