[Long term experience with the LifeSite hemodialysis device]. / Utilisation au long cours des chambres d'hémodialyse "LifeSite".

We present the first report on the long term use of the LifeSite hemodialysis access system in patients who have no possibility of arteriovenous fistula creation. This system consist of a titanium alloy valve and silicone catheter which is placed in a central vein. Conventionally two devices are placed for optimal blood draw and return but single needle dialysis is possible using only one device. We have used this system in six patients since February 1999. Four patients continue to use the LifeSite for dialysis while one patient transferred to peritoneal dialysis because of hemodynamic instability during dialysis and one patient died of mesenteric infarction. Blood flow using two devices is excellent (300-345 ml/min). The infection rate is low (about 1.7 episodes per 1,000 days) and most patients were successfully treated without the need to remove the device. Two patients required temporary removal of one device because of local infection. While this, they were dialysed via a single needle using the remaining device. In our experience the LifeSite system appears a useful alternative in patients in whom a native fistula is not possible and it is able to provide effective dialysis for at least three years.

Angiotensin-converting enzyme inhibitors and kidney protection: the AIPRI trial. The ACE Inhibition in Progressive Renal Insufficiency (AIPRI) Study Group.

A protective effect of angiotensin-converting enzyme (ACE) inhibitors has been shown in patients with diabetic nephropathy but has not been clearly established in nondiabetic renal disease. A multicenter European study was designed to determine whether the ACE inhibitor benazepril was safe and effective in protecting residual renal function in patients with various renal diseases and mild to moderate renal failure. The trial involved 583 patients from 49 centers in Italy, France, and Germany. The patients were randomized to receive benazepril or placebo plus other antihypertensive agents, the target being a diastolic blood pressure of less than 90 mm Hg. Thirty-one patients in the benazepril group and 57 patients in the placebo group reached the end point [the time elapsed from entry to (a) doubling of serum creatinine (SCr) concentrations and (b) start of renal replacement therapy; p < 0.001 at 3 years]. The associated reduction in the relative risk of reaching the end point was 53% in benazepril-treated patients, with actuarial renal survival probability significantly better at 3 years. The best survival of renal function was observed in patients with chronic glomerular diseases and proteinuria greater than 1.0 g/24 h. Benazepril is effective in slowing the rate of progression and improving the survival of renal function in patients with renal diseases of various origins. This protective effect is associated with a clinically relevant decrease in both blood pressure and proteinuria.

Long-term progression of chronic renal insufficiency in the AIPRI Extension Study. The Angiotensin-Converting-Enzyme Inhibition in Progressive Renal Insufficiency Study Group.

The Angiotensin-converting-enzyme Inhibition on Progressive Renal Insufficiency (AIPRI) Study showed that the ACE inhibitor benazepril provides protection against loss of renal function in patients with chronic renal insufficiency (CRI) caused by various renal diseases. As a result of unexpectedly low mortality in the placebo group, there was a substantial imbalance in mortality during the course of this study (8 patients on benazepril vs. 1 on placebo). The aim of the extension study was to follow-up the patients from the AIPRI core study until autumn 1996, focusing on CRI progression and mortality. Data collection was post hoc. Patients were treated according to investigators' usual practices, without knowledge of the core study trial medication or (initially) the core trial results. A new primary efficacy parameter was defined as the time from the start of core study treatment to the occurrence of the first event in the combined composite end-point of dialysis, renal transplantation or death related to renal disease. Serial serum creatinine levels and all-cause mortality were also recorded. The median total follow-up for core + extension periods was 6.6 years. Many patients from both treatment groups (64% on benazepril and 61% on placebo) received ACE inhibitors during follow-up. In the intention-to-treat analysis of the core + extension data, only 79 of 300 patients from the benazepril group, compared to 102 of the 283 patients from the placebo group needed dialysis or renal transplantation, or died related to renal disease (P < 0.013, log-rank test). The mortality imbalance seen in the core trial was not evident with the longer follow-up (25 deaths in the benazepril and 23 in the placebo group, before dialysis). These data clearly demonstrate a long-term beneficial effect in patients randomized to take benazepril during the core study, but because treatment during the extension period was not randomized, the results of this intention-to-treat analysis need to be interpreted with care.

Must erythropoietin be injected by the subcutaneous route for every hemodialyzed patient?

A multicenter, prospective, and controlled trial was performed to evaluate the efficacy and tolerance of intravenous (i.v.) and subcutaneous (s.c.) recombinant erythropoietin (rH-EPO) administration routes in 49 long-term hemodialyzed patients on maintenance phase of treatment, to determine the usefulness of replacing i.v. route by SC route in all of them. Each of these patients had already been treated with rH-EPO by the i.v. route for at least 6 months and included in the protocol on stabilized consumption phase. We arbitrarily chose three strata according to previous needs: Stratum A (> 150 U/kg/week) for eight patients, Stratum B (100 to 150 U/kg/week) for 12 patients, and Stratum C (< 100 U/kg/week) for 29 patients. In each stratum, the further treatment route (i.v. or s.c.) was randomized. Finally, 25 patients continued with i.v. route, and the other 24 changed to the s.c. route. The objective was to maintain a stable hemoglobin level, ranging from 9 to 10 g/dL. Tolerance and consumption in each group (i.v. and s.c.) were compared 4 months later. Globally, for an identical efficacy, rH-EPO needs were lesser using s.c. route (84 U/kg/week) than i.v. route (112 U/kg/week) (P = 0.02). However, when the strata were studied, it transpires that this benefit existed only for consumers having the highest needs (Stratum A) and not for the others. With regard to tolerance, only thrombotic events might be less frequent by using s.c. route, but the significance threshold is not reached (P = 0.09). Thus, replacing i.v. route by SC route, especially in high consumers, reduces the cost of treatment by rH-EPO. This benefit might be dependent on previous needs.

Effect of the angiotensin-converting-enzyme inhibitor benazepril on the progression of chronic renal insufficiency. The Angiotensin-Converting-Enzyme Inhibition in Progressive Renal Insufficiency Study Group.

BACKGROUND: Drugs that inhibit angiotensin-converting enzyme slow the progression of renal insufficiency in patients with diabetic neuropathy. Whether these drugs have a similar action in patients with other renal diseases is not known. We conducted a study to determine the effect of the angiotensin-converting-enzyme inhibitor benazepril on the progression of renal insufficiency in patients with various underlying renal diseases. METHODS: In a three-year trial involving 583 patients with renal insufficiency caused by various disorders, 300 patients received benazepril and 283 received placebo. The underlying diseases included glomerulopathies (in 192 patients), interstitial nephritis (in 105), nephrosclerosis (in 97), polycystic kidney disease (in 64), diabetic nephropathy (in 21), and miscellaneous or unknown disorders (in 104). The severity of renal insufficiency was classified according to the base-line creatinine clearance: 227 patients had mild insufficiency (creatinine clearance, 46 TO 60 ml per minute), and 356 had moderate insufficiency (creatinine clearance, 30 to 45 ml per minute). The primary end point was a doubling of the base-line serum creatine concentration or the need for dialysis. RESULTS: At three years. 31 patients in the benazepril group and 57 in the placebo group had reached the primary end point (P<0.001). In the benazepril group, the reduction in the risk of reaching the end point was 53 percent overall (95 percent confidence interval, 27 to 70 percent), 71 percent (95 percent confidence interval, 21 to 90 percent) among the patients with mild renal insufficiency, and 46 percent (95 percent confidence interval, 12 to 67 percent) among those with moderate renal insufficiency. The reduction in risk was greatest among the male patients; those with glomerular diseases, diabetic nephropathy, or miscellaneous or unknown causes of renal disease; and those with base-line urinary protein excretion above 1 g per 24 hours. Benazepril was not effective in patients with polycystic disease. Diastolic pressure decreased by 3.5 to 5.0 mm Hg in the benazepril group and increased by 0.2 to 1.5 mm Hg in the placebo group. CONCLUSIONS: Benazepril provides protection against the progression of renal insufficiency in patients with various renal diseases.

[Comparison of the efficacy of enalapril + hydrochlorothiazide and captopril + hydrochlorothiazide combinations in mild-to-moderate arterial hypertension by ambulatory measurement of blood pressure]. / Comparaison de l'efficacité des associations énalapril + hydrochlorothiazide et captopril + hydrochlorothiazide parmesure ambulatoire de la pression artérielle sur l'hypertension artérielle légère à modérée.

This two-centre trial compared the efficacy of combinations of enalapril + hydrochlorothiazide (E + H) and captopril + hydrochlorothiazide (C + H) on mild-to-moderate hypertension, after a two-week placebo period, in 26 patients with mild-to-moderate HT (DBP between 95 and 114 mmHg) not controlled by previous treatment, randomized under double-blind conditions into two groups for two 4-week crossover treatment periods separated by a 4-week wash-out period. One group received E + H (20 mg/12.5 mg) followed by C + H (50 mg/25 mg) and the other group received C + H (50/25) followed E + H (20/12.5), once a day. The efficacy of the two treatments was evaluated by 24-hour ambulatory blood pressure monitoring (ABPM) at the start of the study and after each treatment period. Plasma renin activity, aldosterone and angiotensin converting enzyme were assayed under the same conditions. Analysis was based on 26 cases, as none of the patients were withdrawn from the trial. No difference was observed between the two groups in terms of the main biometric and laboratory characteristics. Blood pressure evaluated by ABPM and intermittently was not significantly different between the two groups at the time of inclusion in the study. On intermittent Bp determinations, E + H and C + H decreased diastolic and systolic blood pressure, with no significant difference between the two treatments. On ABPM, the two treatments significantly decreased mean systolic, diastolic and mean blood pressure during the diurnal, nocturnal and circadian periods.(ABSTRACT TRUNCATED AT 250 WORDS)

[Ambulatory blood pressure profile during 48 hours in patients treated with chronic hemodialysis]. / Profil tensionnel ambulatoire de 48 heures chez l'hémodialysé chronique.

Hypertension is one of the severest cardiovascular risk factor in subjects affected by end-stage renal disease in chronic hemodialysis. The behavior of blood pressure between the first hemodialysis (day 1) and the next one (day 2) was studied in 24 untreated normotensive hemodialysis patients. Patients were between 34 and 83 years (mean age: 60 +/- 12 yrs) and were hemodialysed 3 x 4 hours a week, between 7 and 12 a.m. ABP was recorded at 15 minutes intervals between 7 and 22 hours, and 30 minutes intervals during the night, during 48 hours with a Spacelabs 90202 or 90207 device. The following results were observed: ABP is greater at day 2 (122/74 mmHg) than at the first (117/70 mmHg, p less than 0.001); that increase is not correlated with gaining weight during interdialytic period; after hemodialysis, blood pressure continues to fall during 2 or 3 hours until a level of 119 mmHg; low values continue during postdialysis and during the first night; the following day, ABP increases progressively during the morning and during the evening; before the second hemodialysis, the increase is suddenly faster; circadian rhythm is lost in 9/24 patients; in 17/24 patients, nocturnal decrease of BP is lower than 5%; age and ancientness of hemodialysis are the most important factor; rest blood pressure measured by physician before HD is continually higher than diurnal ABP (138/74 vs 121/73 mmHg, p less than 0.001), even if ABP is only analysed during one hour before the second hemodialysis (129/77 mmHg).

[Eradication of hepatitis B in dialysed patients through repeated sero vaccinations]. / Eradication de l'hépatite B chez les dialysés chroniques par séro-vaccinations répétées.

From December 1981 to April 1984, 56 dialysed patients have been enrolled in a sero-vaccination program in which injections of Hevac B vaccine and anti-HBs immunoglobulin have been repeated to obtain anti-HBs response. Anti-HBs antibodies were distinguished from passively transmitted anti-HBs whenever anti-HBs levels above 33 mUI/ml were found 60 days after the last injection of hepatitis B immune globulins (4 ml). Among 39 patients (25 men, 14 women) (mean age 59 years) the proportion of vaccine responders was 44%, 67%, 82%, 90% after respectively 4, 6, 10, 14 injections of Hevac B vaccine. Age, male sex and duration of dialysis were found to decrease the immune response to the vaccine. Multiple injections and maintenance of protective anti-HBs (titer greater than 20 mUI/ml) can be considered as the most effective method to eradicate HBV infection from dialysis centers.

Poplar lignin decomposition by gram-negative aerobic bacteria.

Eleven gram-negative aerobic bacteria (Pseudomonadaceae and Neisseriaceae) out of 122 soil isolates were selected for their ability to assimilate poplar dioxane lignin without a cosubstrate. Dioxane lignin and milled wood lignin degradation rates ranged between 20 and 40% of initial content after 7 days in mineral medium, as determined by a loss of absorbance at 280 nm; 10 strains could degrade in situ lignin, as evidenced by the decrease of the acetyl bromide lignin content of microtome wood sections. No degradation of wood polysaccharides was detected. Lignin biodegradation by Pseudomonas 106 was confirmed by CO(2) release from labeled poplar wood, although in lower yields compared with results obtained through chemical analysis based on acetyl bromide residual lignin determination.

[Late diagnosis of cystinosis in 2 brothers: histological and ultrastructural renal study]. / Cystinose à revelation tardive chez deux frères. Etude histologique et ultrastructurale rénale.

Cystinosis was discovered by chance in two adolescent boys who had proteinuria with minor tubular abnormalities. Renal biopsies were examined by light microscopy, electron microscopy and immunofluorescence. There were few histological changes but crystals were present in the epithelial cells of the glomerulus and occasionally in the tubules. A further unusual feature was the detection of IgA deposits in the mesangium.