Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects ((RAV))
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
調査の概要
詳細な説明
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Linköping、スウェーデン
- Intensive Care Unit, University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy, without allergies and with the age 18 years or above
Exclusion Criteria:
- Heart failure
- Signs of kidney injury/failure
- Severe allergies
- Pregnancy
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：処理
- 割り当て：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 |
|---|---|
|
実験的：Rapid - Slow
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (30 minutes), second time slow (120 minutes). Albumin solution |
Infusion rate and effects
|
|
実験的：Slow - Rapid
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (120 minutes), second time slow (30 minutes). Albumin solution |
Infusion rate and effects
|
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 |
|---|---|---|
|
Plasma volume
時間枠：6 hours
|
Albumin infusion expands the plasma volume and dilutes hemoglobin.
The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
|
6 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Colloid osmotic pressure
時間枠：6 hours
|
Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma.
Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure.
This effect is measured.
|
6 hours
|
|
Fluid recruitment from tissues
時間枠：6 hours
|
The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured.
The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.
|
6 hours
|
協力者と研究者
捜査官
- 主任研究者：Joachim Zdolsek, MD, PhD,Assoc prof、University Hospital, Linkoeping
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
その他の研究ID番号
- RAV
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Albumin solutionの臨床試験
-
Do Hyun ParkHK inno.N Corporation募集
-
Polyak, MaximilianHealth Resources and Services Administration (HRSA)完了
-
Martin-Luther-Universität Halle-Wittenbergまだ募集していません