A Predictive Score System for AKI Following Pediatric Cardiac Surgery
Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery
調査の概要
詳細な説明
The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.
Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.
At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.
This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Jianhui Wang, MD
- 電話番号:+86-010-88398082;
- メール:stewenwang@sina.com
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100037
- 募集
- Fuwai Hospital
-
コンタクト:
- Jianhui Wang, M.D.
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- < 18 years old
- Pediatric patients undergoing cardiac surgery in Fuwai Hospital
Exclusion Criteria:
- Supported by dialysis for renal failure prior to cardiac procedure
- Previously received a renal transplant
- Lack of preoperative or postoperative serum creatinine measurements
- Guardians' refusal on informed consent sign
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
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
AKI
AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
|
介入なし
|
No-AKI
No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
|
介入なし
|
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 |
---|---|---|
The Prevalence of Acute Kidney Injury
時間枠:Up to postoperative 7 days
|
Acute Kidney Injury was defined by Kidney Disease Improving Global Outcomes (KDIGO) Criteria.
Accordingly, AKI was classified as stage 1, stage 2 and stage 3.
|
Up to postoperative 7 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The incidence of dialysis
時間枠:Up to postoperative 7 days
|
The therapeutic approach to correct renal failure
|
Up to postoperative 7 days
|
The hours of mechanical ventilation
時間枠:Up to postoperative 7 days
|
Time before first extubation
|
Up to postoperative 7 days
|
The incidence of reinbutation
時間枠:Up to hospital discharge, an average of 7 days
|
Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
|
Up to hospital discharge, an average of 7 days
|
The incidence of tracheotomy
時間枠:Up to hospital discharge, an average of 7 days
|
The necessary treatment for postoperative respiratory failure
|
Up to hospital discharge, an average of 7 days
|
The incidence of re-operation
時間枠:Up to hospital discharge, an average of 7 days
|
Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.
|
Up to hospital discharge, an average of 7 days
|
The incidence of mechanical cardiac support
時間枠:Up to hospital discharge, an average of 7 days
|
Supported by extracorporeal membrane oxygenation from operative day to discharge or death
|
Up to hospital discharge, an average of 7 days
|
The incidence of mortality
時間枠:Up to hospital discharge, an average of 7 days
|
Specific death reason
|
Up to hospital discharge, an average of 7 days
|
The incidence of pulmonary infection
時間枠:Up to hospital discharge, an average of 7 days
|
Assessed by relevant guidelines of pulmonary infection
|
Up to hospital discharge, an average of 7 days
|
The cost of medical resources
時間枠:Up to hospital discharge, an average of 7 days
|
The RMB patients spend during the whole hospitalization
|
Up to hospital discharge, an average of 7 days
|
Intensive Care Unit Discharge Time
時間枠:Up to ICU discharge, an average of 5 days
|
Time and date when the patient is transferred to ward
|
Up to ICU discharge, an average of 5 days
|
Hospital Discharge Time
時間枠:Up to hospital discharge, an average of 7 days
|
Time and date when the patient is discharged from the hospital
|
Up to hospital discharge, an average of 7 days
|
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge
時間枠:Up to hospital discharge, an average of 7 days
|
(LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline * 100%
|
Up to hospital discharge, an average of 7 days
|
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge
時間枠:Up to hospital discharge, an average of 7 days
|
(LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline * 100%
|
Up to hospital discharge, an average of 7 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year
時間枠:Up to postoperative 1 year
|
(LVEF at 1 year - LVEF at baseline)/LVEF at baseline * 100%
|
Up to postoperative 1 year
|
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 year
時間枠:Up to postoperative 1 year
|
(LVEDD at 1 year - LVEDD at baseline)/LVEDD at baseline * 100%
|
Up to postoperative 1 year
|
協力者と研究者
捜査官
- 主任研究者:Jianhui Wang, MD、Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
- 2021-LC15
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
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