A United Kingdom Multicenter Study of Icodextrin in Continuous Ambulatory Peritoneal Dialysis

1994 ◽  
Vol 14 (2_suppl) ◽  
pp. 22-27 ◽  
Author(s):  
Ram Gokal ◽  
Chandra D. Mistry ◽  
Elizabeth Peers ◽  
C.B. Brown ◽  
S. Smith ◽  
...  

While glucose remains the only osmotic agent used universally for peritoneal dialysis, its various shortcomings for the long dwell equilibration continuous ambulatory peritoneal dialysis (CAPD) has led to a search for alternative agents. The large molecular weight group has been of interest, because these agents theoretically would lead to greater ultrafiltration and a better metabolic profile. Mostsubstances (dextrans, charged macromolecules) have been found unsuitable for reasons of insolubility, allergenicity, and peritoneal toxicity. Short-chain polypeptides have been studied in humans, but the experience is limited, and there is the potential for allergenicity with long-term use. The only large molecular weight agent that has been studied in some detail but hitherto in one center only and in a limited number of patients is glucose polymer (generic name, icodextrin). Because of the promise shown by these initial studies, a randomized controlled multicenter investigation of icodextrin in CAPD (MIDAS Study Group) was undertaken to evaluate the long-term safety and efficacy by comparing daily overnight (8 12 hours) use of a slightly hypo-osmolar solution (282 mOsm/ kg) with 1.36% (346 mOsm/kg) and 3.86% (484 mOsm/kg) glucose exchanges. Over a 6-month period 209 patients from 11 centers in the United Kingdom were randomized, with 106 allocated to receive icodextrin (study group) and 103 to remain on glucose (control group). One hundred and thirty-eight patients completed the 6-month study (71 control, 67 study). The mean net ultrafiltration overnight with icodextrin was 3.5 times greater than 1.36% at 8 hours and 5.5 times greater at 12 hours (p<0.0001), but no different from that of 3.86% glucose at 8 and 12 hours (although for the latter dwell the net mean ultrafiltration volume was greater by about 140 mL). Biochemical profiles were no different except for a small fall in serum sodium and chloride in the icodextrin group. The mean serum maltose rose to a steady-state level of 1.2 g/L within 2 weeks and remained stable. The mean carbohydrate absorbed for icodextrin (29±5 g) was lower than with 3.86% glucose (62±5 g). The use of icodextrin did not increase the incidence of peritonitis, nor did it alter its outcome, affect uptake of icodextrin from the peritoneum, alter serum osmolality or sodium levels. There were no adverse effects associated with the use of icodextrin, and the overall CAPD-related symptom score was significantly better for icodextrin than control subjects. This study and subsequent extensive use and clinical experience has demonstrated that the daily use of an iso-osmolar icodextrin solution is generally well tolerated, effective, and could replace the overnight use of hyperosmotic glucose solution. Its use was of equal efficacy in peritonitis and in diabetic patients. The elevated levels of maltose did not appear to have any clinical side effects.

1989 ◽  
Vol 9 (2) ◽  
pp. 121-125 ◽  
Author(s):  
Francisco Coronel ◽  
Luis Hortal ◽  
Pablo Naranjo ◽  
Carlos Pozo ◽  
Jaime Torrente ◽  
...  

After five years of treating diabetics by continuous ambulatory peritoneal dialysis (CAPD), we analyzed the factors involved in prognosis. Forty-one patients were included in the study, with a cumulative experience of 784 months. Good control of blood glucose was obtained with intraperitoneal (i.p.) insulin and the blood pressure was controlled in 87% of patients without medication, which probably favored the stabilization of visual acuity in 60% of 15 patients evaluated after two years. The follow-up of patients was longer in those who began CAPD with a higher residual creatinine clearance. In spite of the large number of patients who were blind or had very poor vision, 83% of all patients were self-sufficient and well-trained for CAPD, and 39% were able to work full time. The incidence of peritonitis declined to 1 episode per 17.5 patient months associated with the introduction of new preventive measures. Patients over 50 years old had the highest mortality rate and myocardial infarction was the main cause of death. Patient survival at 6, 12, 24, 36, and 42 months was 100, 90, 80, 62, and 62%, respectively. Age and cardiac problems are important factors in survival. Self-sufficiency, rehabilitation, and low incidence of peritonitis are also important factors in the life quality of diabetic patients on CAPD.


1980 ◽  
Vol 1 (5) ◽  
pp. 54-58 ◽  
Author(s):  
Norbert H. Lameire ◽  
Marc De Paepe ◽  
Raymond Vanholder ◽  
Johan Verbanck ◽  
Severin Ringoir

This paper has reviewed experience in Belgium with 99 patients on CAPD. They represent 6-7% of all dialysis patients in this country. The principle reasons for selecting CAPD were old age, problems with vascular access and major cardiovas cular complications. Hemoglobin and hematrocrit values increased in all patients but preliminary measurements of red cell volume in some of them showed no change. Most patients showed moderate increases in serum triglycerides. In three non-diabetic patients with marked elevation in triglyceride levels, insulin, given intraperitoneally, prevented further increases. The frequency of peritonitis was still high; the average rate was one episode every 7.6 patient months. Other major complications included hypotension, which improved after the substitution of dialysate with a higher sodium concentration, severe respiratory disease and gangrene of the legs. After a mean follow-up of seven months, the death rate was 18% and the rate of technical success was 70%. The fact that most of our patients were in the high-risk category should be kept in mind when comparing these results with those obtained with other modes of treatment. At the end of 1978, a total of 1195 patients with end-stage renal disease (ESRD) were treated on either home or hospital dialysis in Belgium. There were 50 dialysis centers for a total population of 9.8 million. Of these 1195 patients, only seven were treated with either continuous ambulatory peritoneal dialysis (2-4) or intermittent peritoneal dialysis. Since then and until July 1, 1980 the number of patients treated with CAPD in Belgium has increased to 99 and this paper describes our experience with these patients.


1983 ◽  
Vol 3 (1_suppl) ◽  
pp. 16-20 ◽  
Author(s):  
C.T. Flynn

Insulin-dependent diabetics with renal failure have a relatively poor long-term survival. The basic issue, therefore, is quality of life. CAPD allows the patient to be independent. The procedure can be performed as well by the blind as by a sighted patient and thus is available to blind diabetics. Intraperitoneal insulin offers a safe, consistent and convenient control of the blood sugar. Our experience suggests that continuous ambulatory peritoneal dialysis is the dialytic treatment of choice for the majority of insulin-dependent diabetic patients.


1999 ◽  
Vol 19 (1) ◽  
pp. 65-70 ◽  
Author(s):  
Harold J. Manley ◽  
George R. Bailie ◽  
Rupesh D. Asher ◽  
George Eisele ◽  
Reginald F. Frye

Objective To investigate the pharmacokinetic parameters of intermittent intraperitoneal (IP) cefazolin, and recommend a cefazolin dosing regimen in continuous ambulatory peritoneal dialysis (CAPD) patients. Design Prospective nonrandomized open study. Setting CAPD outpatient clinic in Albany, New York. Patients Seven volunteer CAPD patients without peritonitis. Three of the patients were nonanuric while 4 were anuric. Interventions Cefazolin (15 mg/kg total body weight) was given to each patient during the first peritoneal exchange. Blood and dialysate samples were collected at times 0, 0.5, 1, 2, 3, 6 (end of the first antibiotic-containing dwell), 24, and 48 hours after the administration of IP cefazolin. Urine samples were collected in nonanuric patients over the study period. Results The mean ± SD amount of cefazolin dose absorbed from the dialysate after the 6-hour dwell was 69.7% ± 8.0% of the administered dose. The cefazolin absorption rate constant from dialysate to serum was 0.21 ± 0.1 /hr (absorption half-life 3.5 ± 0.8 hr). The mean serum concentrations reached at 24 and 48 hours were 52.4 ± 3.7 mg/L and 30.3 ± 5.9 mg/L, respectively. The mean dialysate cefazolin concentrations reached at 24 and 48 hours were 15.1 ± 3.4 mg/L and 7.9 ± 1.4 mg/L, respectively. The cefazolin serum elimination rate constant was 0.02 ± 0.01 /hr (elimination half-life 31.5 ± 8.8 hr). The total cefazolin body clearance was 3.4 ± 0.6 mL/min. In the 3 nonanuric patients the mean renal clearance of cefazolin was 0.6 ± 0.4 mL/min. The peritoneal clearance of cefazolin was 1.0 ± 0.3 mL/min. The systemic volume of distribution of cefazolin was 0.2 ± 0.05 L/kg. No statistical difference was detected in pharmacokinetic parameters between anuric and nonanuric patients, although this may be due to the small number of patients in each group. Conclusion A single daily dose of cefazolin dosed at 15 mg/kg actual body weight in CAPD patients is effective in achieving serum concentration levels greater than the minimum inhibitory concentration for sensitive organisms over 48 hours, and dialysate concentration levels over 24 hours. Caution is warranted in extrapolation of dosing recommendations to patients who maintain a significant degree of residual renal function.


1994 ◽  
Vol 24 (5) ◽  
pp. 826-837 ◽  
Author(s):  
Antonio Lupo ◽  
Renzo Tarchini ◽  
Giovanni Cancarini ◽  
Luigi Catizone ◽  
Roberto Cocchi ◽  
...  

1986 ◽  
Vol 70 (1) ◽  
pp. 23-29 ◽  
Author(s):  
A. Heaton ◽  
M. K. Ward ◽  
D. G. Johnston ◽  
K. G. M. M. Alberti ◽  
D. N. S. Kerr

1. Six patients established on continuous ambulatory peritoneal dialysis entered a trial of treatment with dialysis fluid containing glycerol instead of glucose as the osmotic agent in an attempt to decrease the energy load. They were observed for a further 6 months after reconversion to glucose-based dialysis. 2. During the 6 month control period fluid balance was achieved mainly with a solution containing 76 mmol of glucose/l. Fluid balance was maintained during the 6 month period of treatment with glycerol only by the increased use of solutions containing a high concentration of glycerol (152 mmol/l and 272 mmol/l). Thus the energy value of the absorbed osmotic agent did not differ at a mean of 1607 kJ (384 kcal)/day using glycerol and 1669 kJ (399 kcal)/day using glucose as the osmotic agent. 3. In five subjects, fasting and peak blood glycerol levels did not change over the 6 months, but one subject, who accumulated glycerol, developed symptoms of hyperosmolality after 2 months and glycerol therapy was discontinued. In a further subject glycerol-based dialysis was terminated at 3 months when increasing angina was reported. 4. Mean fasting plasma triglyceride concentrations were 50% higher during the 6 months on glycerol (3.12 ± 1.12 mmol/l) than on glucose (2.19 ± 0.97 mmol/l) (P < 0.05). There was a small rise in very low density lipoprotein-cholesterol concentrations with glycerol dialysis but total cholesterol levels were unchanged. 5. The absorption of glycerol was not associated with an acute rise in circulating glucose or insulin but the mean blood glucose, over a 6 h dialysis cycle, had risen by 0.5 mmol/l after 3 months' treatment with glycerol and the mean serum insulin had risen from 5.9 ± 0.7 m-units/l to 9.8 ± 0.6 m-units/l (P < 0.01). 6. This study demonstrated no substantial advantage of glycerol over glucose as an osmotic agent in non-diabetic patients on continuous ambulatory peritoneal dialysis.


1999 ◽  
Vol 19 (2_suppl) ◽  
pp. 242-247 ◽  
Author(s):  
Theofanis Apostolou ◽  
Ram Gokal

Oiabetes mellitus is the commonest cause of end-stage renal failure and is associated with considerable morbidity. Neuropathy is one of the most serious complications of diabetes, linked to the incidence of nephropathy and retinopathy. The prevalence of neuropathy increases with age and duration of diabetes. Peripheral sensorimotor neuropathy is the main manifestation of neurological dam -age in diabetes, while autonomic neuropathy, a devastating complication, is also present in a large number of patients with long-term diabetes. Clinical features of autonomic neuropathy are mainly cardiovascular disorders and abnormal visceral function. One of the most important sequelae of neuropathy is the development of the insensitive foot at risk of ulceration, deformation, Charcot neuroarthropathy, and amputation. Prevention, education, and identification of the at-risk patient are the key elements in managing these severe complications. Oialysis, and mainly peritoneal dialysis, still remains the main renal replacement therapy for end-stage renal disease (ESRO) diabetic patients. It is obvious from many studies that diabetes and its complications are major risk factors associated with poorer survival rates, increased morbidity, and decreased quality of life. Few, if any, data are available specifically evaluating quality of life in continuous ambulatory peritoneal dialysis (CAPO) diabetic patients. Fewer data are available estimating the impact of neuropathy on the quality of life of such patients. Specific studies must be carried out to further investigate quality-of-life issues and neuropathy in this vulnerable group of patients.


1981 ◽  
Vol 2 (1) ◽  
pp. 13-16 ◽  
Author(s):  
Hans Jakob Gloor ◽  
Harold Moore Karl ◽  
D. Nolph

We measured digoxin concentrations in serum and dialysate from five digitalized patients on continuous ambulatory peritoneal dialysis (CAPD). Mean peritoneal clearance of digoxin was 3.6 ± 0.4 ml/min (± SEM). Mean mass transfer was 8.6 ± 0.6 μg/min. Our patients lost from 3.7 to 13.3% of their daily oral digoxin intake in dialysate. The mean dialysate over serum (D/S) digoxin ratio was 0.59 and fell between D/S creatinine (0.81) and D/S inulin (0.34). Between patients the range of this ratio was wide (0.25 to 0.90). We also measured serial digoxin dialysate concentrations during a six hour “dwell” in one patient and determined a D/S equilibration curve. After six hours dialysate digoxin approached a plateau near 0.5. Digoxin removal per week from dialysate was two to three times greater during CAPD than that reported from IPD. Peritoneal losses of digo xin cannot be predicted for an individual patient. In four of eight digitalized patients, the cardiac drug could be discontinued suggesting a beneficial effect of long-term CAPD in controlling congestive heart failure.


1996 ◽  
Vol 7 (3) ◽  
pp. 454-463
Author(s):  
E W Weiler ◽  
L F Saldanha ◽  
F Khalil-Manesh ◽  
B A Prins ◽  
R E Purdy ◽  
...  

Inhibitors of sodium-potassium-activated adenosine triphosphatase (Na-K-ATPase) have been implicated in the pathogenesis of hypertension. In the study presented here, an attempt was made to determine whether differences in the plasma levels and the removal rates of high-molecular weight (HMW) and low-molecular weight (LMW) forms of Na-K-ATPase inhibitors might relate to blood-pressure control in hemodialysis (N = six ultrafiltered and N = six non-ultrafiltered) and CAPD (N = six long-term and N = five short-term) patients. The latter group was studied before the initiation of continuous ambulatory peritoneal dialysis (CAPD) and 2 wk after starting the treatment. The mean blood pressure was significantly reduced after dialysis in the nonultrafiltered hemodialysis group and in both CAPD groups. Plasma levels of both HMW and LMW inhibitors were found to be elevated before dialysis in all patients and were modified only slightly after dialysis. Irrespective of whether ultrafiltration was utilized in hemodialysis patients and despite significant losses of both HMW and LMW inhibitors into CAPD effluent. Because CAPD effluent was found to contain vasopressors that were not exclusively Na-K-ATPase inhibitors, losses of these other vasopressors may contribute to improved blood-pressure control in CAPD in contrast to hemodialysis.


1986 ◽  
Vol 6 (2) ◽  
pp. 58-61 ◽  
Author(s):  
Alberto Cantaluppi ◽  
Antonio Scalamogna ◽  
Claudia Castelnovo ◽  
Giorgio Graziani

We have already described (Lancet 1983, ii, 642) the results of a controlled study in two centres showing the efficacy of a Y-shaped connector, filled with sodium hypochlorite during the dwelling time, for the reduction of peritonitis: one episode every 33 patient-months in the treated group versus one episode every 11.3 patient-months in the control group using the standard method. During the past 2.5 years we have continued to use the Y-connector. All new patients referred to our hospital for initiation of CAPD program were trained to use the Y-connector, while those patients already on the standard Y-connector continued on it. From January 1983 to June 1985, among 18 non-diabetic patients using the standard bag-exchange method, there were 23 peritonitis episodes in 14 patients (78%) over a cumulative period of 257 months -one episode every 11.2 patient-months. In contrast, among the 92 patients using the Y-connector, there were 30 peritonitis episodes in 21 patients (22.8%) during 1354 months -one episode every 45.1 patient-months. When we exclude from this group the 10 diabetic patients adding insulin to the bags, the incidence of peritonitis fell to one episode every 92.2 patientmonths. These results confirm that the Y-connector is extremely effective in reducing the rate of peritonitis in patients on CAPD. The most widely accepted technique for prevention of peritonitis in patients on continuous ambulatory peritoneal dialysis (CAPD) is that described by Oreopoulos et al (I). However, to reduce further the risk of dialysis-fluid


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