Peritoneal Transport With a New Bicarbonate-based Peritoneal Dialysis Solution Compared to Conventional Solution.
調査の概要
状態
詳細な説明
Patients treated with peritoneal dialysis (PD)are investigated twice of different days with a single 4h dwell study: once with solution with a solution with bicarbonate 15 mmol/L abd Lactate 15 mmol/L as buffer (Physioneal TM) and once with conventional lactate-buffered (40 mmol/L) PD solution (Dianeal TM). Aproximately 2 liter of PD solution was infused each time. Intraperitoneal fluid was sampled during the dwell at t = 0, 3, 6, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes from the end of the dialysis fluid infusion and the start of the peritoneal dwell. Venous blood samples were drawn from the patient before the start of the dwell and at t = 15, 60, 120, 240 minutes.
New and spent dialysate bags were weighed before and after each dwell to assess infused and drain volumes, respectively; the volumes were adjusted for the weight of the empty bags. Radio-iodinated serum albumin (RISA) added to the solutions before infusion was used as volume marker to estimate intraperitoneal volume. The residual volume (after the previous dwell) was calculated from the dilution of the marker upon infusion of fresh dialysate; after the dwell the peritoneal cavity was rinsed with 1 liter of solution (glucose 1.36%) in order to estimate post-drain residual volume.
Ultrafiltration volume was calculated from the changes in intraperitoneal volume (using 3 minutes after infusion as reference) and corrected for volumes of taken samples. The rate of peritoneal absorption was estimated from the disappearance of the marker from the peritoneal cavity].
The composition of the pre-dialysis (residual) fluid was assessed based on the sample taken from the spent dialysate from the previous dwell.
Concentrations of urea, creatinine, glucose, phosphate, chloride, and lactate, in plasma and dialysate, were measured by Monarch 1000 (Instrumentation Laboratory, MA), while flame photometry was used for sodium and potassium. Dialysate pH was measured with a pH meter. The concentrations of calcium, CO2, bicarbonate, and plasma pH were measured by AVL OMNI Combi Blood Gas Analyzer (AVL, Graz, Austria). The plasma concentrations of glucose, sodium, urea, creatinine, potassium, chloride, and phosphate were corrected for plasma water fraction. Creatinine measurements in dialysate were corrected for glucose concentration. Albumin and beta-2 microglobulin (B2M) concentration were measured with immunological methods.
Advanced mathematical modelling is used to analyze the results and tgo asses transport parameters.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Stockholm、スウェーデン、S-141 86
- Research unit, renal medicine
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- patient treated with peritoneal dialysis in a clinically stable condition
Exclusion Criteria:
- none
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:非ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Bicarbonate lactate solution investigatd first
The patients were studied with the bicarbonate-lactate solution the first study day and with conventional lactate.based
solution on a later day.
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All patients were studied twice with a 4-h dwell study (one peritoneal dialysis dwell) about 7 days apart.
The two arms represent different order of the used periteonal dialysis fluid for the two dwell studies.
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実験的:Lactate solution investigated first
The patients were studied with the conventional lactate.based
solution the first study day and with bicarbonate-lactate solution on a later day.
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All patients were studied twice with a 4-h dwell study (one peritoneal dialysis dwell) about 7 days apart.
The two arms represent different order of the used periteonal dialysis fluid for the two dwell studies.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in net ultrafiltration (ml)
時間枠:4 hours
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Assessment of fluid transport during a PD dwell.
Intraperitoenal volume changes during the 4 hour dwells will be assesed from dilution of the added volume marker with correction for absorption of the marker.
Amount of marker remaining in the drained fluid after four hours will be subratcted from the initial added amount to calculate amount of marker absorbed during the dwell.
Residual volumes before and after the dwell can also be calculated from dilution of the marker.
This makes it possible to calculate the intraperitoneal volume of time curve during the dwell and net ultrafiltration (=net fluid removal).
To simplify, the intraperitoneal volume (ml) at 240 minutes of the dwell minus the intraperitoneal volume after infusion of the dialysis fluid.
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4 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes to acid-base homeostasis
時間枠:4 hours
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Assessment of pH, concentrationa of bicarbonate and lactate i dialysate and plasma.
Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times.
For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate.
The latter is calculated adding up the mass in residual and infused fluids.
As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) the difference in pH between the solutions over time of the dwell may be described.
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4 hours
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Differences in small solute transport
時間枠:4 hours
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Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times for several small solutes.
For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate.
The latter is calculated adding up the mass in residual and infused fluids.
As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) it makes it possible to assess if pH affects transport characteristics of other solutes, in particular small solutes (Na, K, Ca, bicarbonate, lactate, creatinine, urea).
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4 hours
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Differences in protein transport
時間枠:4 hours
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Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times for several small solutes.
For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate.
The latter is calculated adding up the mass in residual and infused fluids.
As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) it makes it possible to assess if pH affects transport characteristics of proteins (albumin and beta-2-microglobuline).
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4 hours
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Dnr 283/96
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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