Stability of erythromycin lactobionate in peritoneal dialysate solutions.
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Biomedical subjects
Publications and source records attributed to G Eisele.
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Thirty-three moderate hypertensives were converted to a 2-drug regimen of metoprolol and diuretic and BPs stabilized at a well-controlled level. They then completed one of three conditions over an 8-week interval: (I) 16 sessions of TBF (hand and foot warming); (II) 16 sessions of frontal EMG-BF; (III) regular home monitoring of BP. Attempts were then made to withdraw the patients from the sympatholytic medication. Those successfully withdrawn were followed up for one year. There were no significant advantages for TBF over the other two conditions in the short term or with long-term follow-up. Only 27% of treated patients (including Condition III failures who were remedicated and treated with TBF) were successfully off of the sympatholytic at a one-year follow-up. The generally poor results on clinical outcome were confirmed by clinic BPs, home BPs by patients, and 24-hour ambulatory BPs.
We report experience with O-set and UVXD systems. Sixty-nine O-set patients (34 male; mean age +/- SD = 45.7 +/- 13.2 years) were compared with 54 UVXD patients (27 male; 56.8 +/- 16.8 years). Total (mean +/- SD) experience were 974 (14.1 +/- 10.8) months on O-set and 1010.9 (18.7 +/- 15.7) months on UVXD. Thirty-two O-set patients avoided peritonitis; 37 had 91 episodes. Seventeen UVXD patients avoided peritonitis; 37 had 137 episodes. Peritonitis occurred each 10.7 months (O-set) versus 7.4 months (UVXD), which was significantly different (p = 0.032, Z test; 95% confidence interval = -0.142 to +0.226). There were 18 relapses in 9 O-set patients, 34 in 12 UVXD. Gram-positive organisms caused 58.2% and 66%; gram-negative, 13.2% and 8.8%; and culture negative, 24.2% and 23.4% of peritonitis in O-set and UVXD, respectively. The time to first peritonitis was not different, 7.4 +/- 6.6 months O-set and 7.2 +/- 7.9 months (UVXD). There was no difference in the peritonitis-free period, 13.0 +/- 10.0 months (O-set) and 16.5 +/- 14.3 months (UVXD). There were 1.12 (O-set) and 16.1 (UVXD) cases per patient year, and 10.7 (O-set) and 7.43 (UVXD) patient months per episode. The peritonitis rate odds ratio was 1:1.85 (O-set:UVXD).
Inpatients at the Albany Medical Center Hospital in Albany, New York are transported from their ward to the hemodialysis unit for their dialytic procedures. The time involved is several hours. An investigation into the timeliness of medication administration during this off-the-ward period was prospectively conducted. Twenty-eight dialytic procedures (for eight different patients), including 127 scheduled medication administrations, were included in the final data. A total of 108 (85%) of audited medication administrations were given more than 1 hour early, 1 hour late, or not at all. Recommendations for corrective action are proposed.
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Two patients with severe liver disease complicated with ascites were recently treated at our institution. Both rapidly developed renal failure. In one patient, liver disease was the result of alcohol abuse, and in the other, was due to malnutrition associated with obesity and acute weight loss. The only reasonable therapeutic approach for these patients was believed to be a course of peritoneal dialysis, along with other supportive measures. In both cases, the management was successful. Furthermore, it was possible to discontinue dialysis at the time of discharge. We conclude that peritoneal dialysis can be a life-saving procedure in patients with severe liver disease and ascites complicated by renal failure.
OBJECTIVE: The primary objective of this article is to review the mechanics, advantages, complications, pharmacokinetics, and future trends of continuous ambulatory peritoneal dialysis (CAPD) as they pertain to pharmacotherapy. DATA SOURCES: Pertinent articles were obtained from an English-language literature search using MEDLINE (1980-1991), Index Medicus (1987-1990), and bibliographic reviews of review articles. Indexing terms included peritoneal dialysis, pharmacokinetics, peritonitis, vancomycin, and fluoroquinolones. DATA SYNTHESIS: All clinical studies comparing organism recovery methods and treatment of peritonitis have methodologic limitations (e.g., comparison of disparate patient groups, different definitions of peritonitis, lack of follow-up, lack of control for sterile cultures) that may affect the reported results. CONCLUSIONS: CAPD is an alternative to hemodialysis for the treatment of endstage renal disease and has many complications, leading to significant morbidity. This indicates that CAPD is not appropriate for all patients. Using blood-culturing techniques to culture for dialysate is most productive, but also the most costly. There are few data to indicate exactly the drugs, doses, and durations of choice for peritonitis. Both intraperitoneal and oral administration appear to be appropriate.
The pharmacokinetics of vancomycin were studied in continuous ambulatory peritoneal dialysis patients with peritonitis. Six patients received an intraperitoneal loading dose of 15 mg/kg and 4 received an intraperitoneal dose of 25 mg/L. The ability of 2 methods to predict serum concentrations during the loading dose exchange was determined. The mean serum concentration after the exchange was 17.8 +/- 2.2 mg/L in patients receiving the loading dose. The mean dialysis clearance in all patients was 0.94 +/- 0.34 L/h. 66.6 +/- 13.4% of a dose was absorbed into the circulation in 4 h. The volume of distribution was 0.61 +/- 0.46 L/kg, and the half-life for equilibration of vancomycin into the circulation from dialysate was 2.76 +/- 0.94 h. Two methods of predicting serum vancomycin concentrations were tested, with 1 method predicting values significantly different from measured concentrations while the other did not. Serum vancomycin concentrations can be accurately predicted during a loading dose exchange.
This study was designed to retrospectively review the experience in this center with oral ciprofloxacin 500 mg bid and ip vancomycin 25 mg/L in the treatment of CAPD-related exit site infections and to determine the relationship between exit site infections and peritonitis. There were 48 patients with 172 episodes of infection (23 had both infections, 22 had peritonitis only, 3 had exit site infections only). Thus, exit site infections occur infrequently in the absence of peritonitis (23% of occasions). Of the 35 patients who had peritonitis as the first infection, 13 (37%) subsequently developed an exit site infection. The mean +/- SD period from an initial peritonitis to a subsequent exit site infection in these patients was 8.2 +/- 8.0 (range 1-28) months. Of the 22 patients with 34 exit site infections, there were 15 (44%) treatment failures, of which 10 (67%) were relapses or possible relapses. S. aureus was the most common isolate. 5% of exit site infections were culture negative. Follow-up was incomplete for many patients resulting in many instances of no further cultures, and compliance could not be assured. This combination was associated with a high incidence of treatment failures in this setting.
Experience in the use of subcutaneous erythropoietin (EPO) in 32 continuous ambulatory peritoneal dialysis (CAPD) patients is presented. All patients were treated with oral iron supplements. The total and mean +/- SD durations of EPO treatment were 466 weeks and 14.6 +/- 10.1 weeks respectively. Twenty-two patients started treatment with normal or elevated iron stores; 10 had an initial iron saturation less than 20%. The initial hematocrit was 23.8 +/- 3.7%. Thirteen patients reached a steady-state hematocrit by the end of the study period, when the mean +/- SD hematocrit for all 32 patients was 34.1 +/- 3.6%. All patients responded to EPO. The initial dose of EPO was 147.1 +/- 53.8 U/kg/week. Maintenance dose was 72 +/- 36 U/kg/week.
A case of chemical peritonitis associated with intraperitoneal vancomycin is reported. A 23-year-old woman presented with signs and symptoms consistent with a chronic ambulatory peritoneal dialysis catheter exit-site infection. Intraperitoneal vancomycin (Vancoled) 1 g was given, followed by 25 mg/L into each subsequent exchange. On day 4 the patient developed abdominal pain and cloudy dialysis effluent. The vancomycin was discontinued, and the dialysate cleared by day 8. Fluid cultures were negative, and Staphylococcus aureus was isolated from the exit site. Subsequent intravenous vancomycin, and smaller intraperitoneal doses, failed to repeat the event. Fluid and serum white blood cell count, serum immunoglobulins and complement, culture results, and the temporal relationship are strongly suggestive of a vancomycin-induced chemical peritonitis.
Experience in the use of subcutaneous erythropoietin in 18 CAPD patients is presented. The total and mean (SD) durations on CAPD were 419 and 23.3 (20.5) months, respectively. Eleven patients started treatment with normal or elevated iron stores, 7 had an initial iron saturation less than 20%. The initial hematocrit was 22.0 (3.1%). Eleven patients reached a steady state hematocrit (34.1 +/- 3.5%) by the end of the study period, and the mean percentage increase in hematocrit for all 18 patients was 47% over the initial hematocrit. All patients responded to EPO. The initial dose of EPO was 157.6 U/kg/wk, and all patients received oral iron supplements. There was no significant change in the means of any iron parameters. Transfusion requirements decreased from a mean of 0.42 transfusions per month per patient during the 12 months, prior to EPO, to 0.22 during the study. There were no significant changes in blood pressure or other measured parameters. Transient pain at the site of injection was noted infrequently.
This report discusses the principles, techniques, and application of whole-body counting with respect to previous radiation exposure. Whole-body counting facilities are located nationwide and have a wide range of capabilities. A listing of these facilities is provided in Appendix A. However, only a few facilities are truly state-of-the-art and have the sophisticated capabilities required to attempt detection of low-level activity in vivo. Measurements made many years after exposure can be extremely difficult to interpret. The precision and accuracy of resulting dose estimates are functions of such factors as the assumptions made concerning intake, time since intake, radionuclide metabolism, and level of intake. The indiscriminate application of metabolic models to current body contents or minimum detectable amounts of radionuclides with relatively short effective half-lives (such as 137Cs) can lead to absurd results when used as a basis for calculating intakes 25 and 40 y ago. Skull counting for 90Sr-90Y and 239,240Pu can set upper limits on possible uptakes and radiation doses, but in the case of 239,240Pu, the limits are rather high. In both cases, the accuracy of the limits depends on the metabolic models used in the calculations. These models (ICRP 1979) were developed to set safety standards for the intakes of radionuclides by workers and are not intended to be used to back-calculate uptakes and radiation doses from measurements made long after the uptake. There are, therefore, large uncertainties in any conclusions derived from these calculations. The experience gained over the years with whole- and partial-body counting has consistently shown that they are of little use in determining body contents of radionuclides resulting from exposure to weapons debris decades earlier. The development of new detectors such as an array of lithium-drifted silicon devices offers some hope of lowering the minimum detectable amount (MDA) for Pu and Am, but such detectors are still several years from routine application and do not represent current state-of-the-art. Furthermore, it is doubtful that such improvements will be sufficient to meet the need of assessing radiation exposures that occurred decades earlier.
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Hematologic changes following whole-body exposure to gamma or x-ray radiation have been used to estimate dose. The usefulness of this biological indicator is limited because of the recovery of these cells with time, thus making it unsuitable for estimation of dose years after exposure. The same is true for spermatogenic indicators; recovery and restoration of sperm numbers and fertility makes this biological indicator impractical for assessing radiation dose decades after radiation exposure. As noted in the text of the report, immunological concepts are in a state of rapid development, and it is possible that improved methods for applying immunologic procedures as biological indicators of radiation may be developed in the future. However, at the time, immunological indicators are not useful, even in an early time period, for quantitating radiation dose after total-body irradiation. A semiquantitative effect is observable in the early phase after total-body irradiation over a period of days to weeks, but there is little data available to indicate whether any of the immunological parameters can be indicative of a dose when the test is applied several years after radiation exposure. More detailed information regarding immunological indicators for estimating irradiation dose has been summarized elsewhere (Wasserman 1986). There is good agreement that ionizing radiation causes biochemical changes in the body; however, attempts to apply these changes to provide a reliable biological dosimetry system have not been particularly successful. The status of this research has been summarized by Gerber (1986). One of the difficulties has been the problem of establishing clear dose-effect relationships in humans. The lack of specificity in the response for radiation is another problem. Additional problems are due to the strict time dependency of biochemical changes and the limited duration of the changes during the postexposure period. Information on biochemical indicators is based on animal experiments; human experience is limited to a relatively few accidental human exposures and investigations involving patients undergoing radiation therapy. It appears that none of the biochemical indicators studied are currently useful for radiation dosimetry. Even if further developed, it is questionable whether or not biochemical indicators could be of use in estimating radiation dose received years and decades prior to the assay.
This report was prepared by a working group established by the Oak Ridge Associated Universities (ORAU) for the purpose of assessing the current capabilities of bioassay methods that can be used to determine the occurrence and magnitude of a previous internal deposition of one or more radionuclides. The first five sections discuss general features of the use of in-vitro bioassay samples to achieve this purpose. The remainder of the report is focused on the possible use of urine bioassay procedures to detect and quantify internal depositions of radionuclides that may have occurred in United States occupation troops in Hiroshima or Nagasaki, Japan, prior to 1 July 1946, or to personnel who participated in atmospheric nuclear weapons tests conducted between 1945 and 1962. Theoretical calculations were made to estimate the quantities of various radionuclides produced in a 20-kiloton (kt) nuclear detonation that might still be present in measurable quantities in people today if they were exposed 25 to 40 y ago. Two radionuclides that emerged as good choices for this type of bioassay analysis were 90Sr, which emits beta particles, and 239,240Pu, which emits alpha particles. The current status and future prospects of chemical procedures for analyzing in-vitro urine bioassay samples for these two radionuclides were examined to determine the minimum amounts that could be detected with current methods and how much one might expect the sensitivity of detection to improve in the near future. Most routine 239,240Pu bioassay analyses involve detection by alpha spectrometry. The current minimum detectable amount (MDA) is about 0.74 mBq L-1 (20 fCi L-1), but this could be lowered to 74 muBq L-1 (2 fCi L-1). An MDA of 0.74 mBq L-1 (20 fCi L-1) is adequate for routine bioassay analyses but is too high to detect most uptakes of 239,240Pu that may have occurred 25 to 40 y ago. Methods under development that are or can be much more sensitive and have lower MDAs than alpha spectrometry for 239Pu are fission track analysis and mass spectrometry. Currently, the fission track analysis method has an MDA of about 19 muBq L-1), and this may eventually be lowered to 1.9 muBq L-1 (0.005 fCi L-1). The current MDA for 239Pu by mass spectrometry is about 7.4 mBq L-1 (200 fCi L-1), but the potential exists that it could be lowered to a value of about 0.37 muBq L-1 (0.01 fCi L-1).(ABSTRACT TRUNCATED AT 400 WORDS)
The effect of incubation temperature and duration was studied on the growth of organisms in peritoneal dialysate effluent. Penicillin-sensitive, and gentamicin-sensitive clinical isolates of S. epidermidis (SE) and E. Coli (EC), respectively, were inoculated into freshly drained dialysate of 19 CAPD patients who did not have peritonitis. Each dialysate was 1.5% dextrose in strength and had a minimum dwell of 6 hours. Control and test aliquots were incubated at 4 degrees C, 20 degrees C and 37 degrees C for periods of up to 12 hours, and samples collected and plated to determine colony counts. Initial counts at time zero were 9.4 x 10(4) (SE) and 6.6 x 10(3) (EC) CFU/ml. SE showed no change in count at 4 or 20 degrees C up to 12 hours. There was a significant increase (p less than 0.005) at 37 degrees C, at 12 hours to 1.72 x 10(6) CFU/ml. EC showed no change at 4 or 20 degrees C. There was a significant decrease in count for EC at 37 degrees C, 6 hours (5.5 x 10(2) CFU/ml, p less than 0.01) and 37 degrees, 12 hours (2.9 x 10(2) CFU/ml, p less than 0.0001). It is recommended that infected dialysate should be stored in cool conditions until it can be transported for culture to ensure adequate recovery of gram negative organisms.
Fifty-nine patients returned a confidential mailed questionnaire, to determine their procedures for disposal of CAPD waste including bags, fluids and needles, and to assess their instruction and opinions on health risks from their wastes. Patients came predominantly from rural communities. Sixty four percent used disposal boxes for used needles, 80% discarded drained bags in the garbage without wrapping them in plastic and 7 to 17% of patients discarded needles straight to the garbage, depending on circumstances. Thirty seven percent did not recall receiving instruction on waste disposal, and of those who did, instructions came predominantly from nurses. Twenty of 32 patients who had suffered peritonitis disposed of their bags during peritonitis in the same manner as when they did not have peritonitis. Most patients (61%) felt issues dealing with CAPD waste disposal were "important" or "very important", but fewer "agreed" or "strongly agreed" that it posed a health risk to others (16%) or to the environment (10%). Inconsistencies in methods of disposal and potential risks of infection dictate that guidelines must be developed to deal with these issues.