The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients
The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure.
The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.
調査の概要
詳細な説明
Acute renal failure is a major and serious complication of more than 200,000 cardiovascular surgeries performed on adult Americans annually (www.sts.org). The incidence of acute renal failure (ARF) after cardiac surgery (depending on criteria used to define ARF) is 1-5%, in the absence of preexisting renal dysfunction. The subset of patients with thoracic aortic aneurysm surgery have a higher risk for the development of postoperative ARF (25-40% - ARF defined as doubling of serum creatinine; 13% - ARF defined as requirement for dialysis). This risk is further increased by various peri-operative factors, especially cardiopulmonary bypass time.
The overall postoperative mortality rate for cardiovascular surgery is 2.2%, but is much higher for thoracic aortic aneurysm surgery (8-10% for elective repair, 25-50% for ruptured thoracic aorta aneurysm repair). The major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative ARF requiring dialysis. When thoracic aortic aneurysm surgery is complicated by acute renal failure, the mortality rate worsens to 50%. Thus, identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery. A retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality, when the medication is used prophylactically.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Florida
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Gainesville、Florida、アメリカ、32610
- 募集
- Shands Hospital at the University of Florida
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コンタクト:
- Richard A Finlay, RN
- 電話番号:352-273-5356
- メール:finlara@medicine.ufl.edu
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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:
- Age 18 years or older
- Undergoing thoracic aortic aneurysm surgery
- Impaired renal function
Exclusion Criteria:
- Prior history of allergy/adverse reaction to Nesiritide
- History of any organ transplant
- Preoperative intra-aortic balloon pump (IABP)
- Decompensated congestive heart failure (CHF)
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
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 |
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Need for dialysis and/or mortality
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二次結果の測定
結果測定 |
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Rise in serum creatinine
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blood urea nitrogen
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Dass B, Shimada M, Kambhampati G, Ejaz NI, Arif AA, Ejaz AA. Fluid balance as an early indicator of acute kidney injury in CV surgery. Clin Nephrol. 2012 Jun;77(6):438-44. doi: 10.5414/cn107278.
- Ejaz AA, Beaver TM, Shimada M, Sood P, Lingegowda V, Schold JD, Kim T, Johnson RJ. Uric acid: a novel risk factor for acute kidney injury in high-risk cardiac surgery patients? Am J Nephrol. 2009;30(5):425-9. doi: 10.1159/000238824. Epub 2009 Sep 11.
- Ejaz AA, Martin TD, Johnson RJ, Winterstein AG, Klodell CT, Hess PJ Jr, Ali AK, Whidden EM, Staples NL, Alexander JA, House-Fancher MA, Beaver TM. Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery. J Thorac Cardiovasc Surg. 2009 Oct;138(4):959-64. doi: 10.1016/j.jtcvs.2009.05.014. Epub 2009 Jul 3.
研究記録日
主要日程の研究
研究開始
研究の完了
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。