Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy (DSI-CRRT)
Continuous renal replacement therapy (CRRT) is commonly used in critically ill patients with acute kidney injury. A frequent complication of CRRT is a drop in blood pressure that requires treatment, known as CRRT-associated hemodynamic instability. This complication is linked to higher mortality and poorer kidney recovery.
The diastolic shock index (DSI) is a simple bedside measure calculated by dividing heart rate by diastolic blood pressure. It requires no additional devices, blood tests or invasive procedures, and higher values have been associated with vasopressor need and mortality in septic shock.
This prospective observational study aims to determine whether DSI measured before the start of CRRT can predict hemodynamic instability during CRRT in adult intensive care unit patients. The predictive performance of DSI will also be compared with the classic shock index, the modified shock index and mean arterial pressure. All data will be obtained from routine clinical monitoring; no additional intervention will be performed for the study.
調査の概要
詳細な説明
Background: CRRT-associated hemodynamic instability (CRRT-HI) complicates 19-43% of CRRT sessions and is independently associated with increased mortality and impaired renal recovery. The diastolic shock index (DSI = heart rate / diastolic arterial pressure) reflects both vascular tone (diastolic pressure) and neurohumoral compensation (heart rate) and has been proposed as an early marker of vasoplegia. Its predictive value for CRRT-HI has not been prospectively evaluated.
Objective: To evaluate the diagnostic performance of pre-CRRT bedside DSI in predicting CRRT-HI in critically ill adults.
Design and setting: Prospective observational cohort study conducted in the general intensive care units of Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey. Approximately 70 adult patients (≥18 years) starting CRRT for acute kidney injury will be enrolled.
Definition of CRRT-HI: An event meeting at least one of the following criteria: mean arterial pressure below 65 mmHg; initiation of a new vasopressor or an increase of ≥20% in the norepinephrine dose; crystalloid fluid bolus exceeding 250 mL; or reduction or discontinuation of ultrafiltration.
Data collection: Demographic and clinical characteristics (APACHE II, SOFA-2, comorbidities, CRRT indication and AKI stage), CRRT settings (modality, blood flow, dialysate and replacement fluid rates, ultrafiltration rate, anticoagulation), and baseline laboratory parameters (arterial blood gas, lactate, complete blood count, renal and liver function tests, electrolytes, CRP, procalcitonin) will be recorded. Heart rate, systolic, diastolic and mean arterial pressures, vasopressor/inotrope use and doses will be recorded at CRRT initiation (T0) and at 15, 30, 60 and 180 minutes. DSI, the classic shock index (HR/SAP) and the modified shock index (HR/MAP) will be calculated from these routine monitoring data. No additional blood sampling, tests or invasive procedures will be performed for the study.
Statistical analysis: The predictive performance of DSI, the classic shock index, the modified shock index and mean arterial pressure will be assessed by ROC curve analysis and compared using the DeLong test. Optimal cut-off values will be determined by the Youden index, with corresponding sensitivity and specificity. Independent risk factors for CRRT-HI will be identified by multivariable logistic regression. Associations of DSI and CRRT-HI with 28-day mortality, ICU and hospital length of stay, duration of mechanical ventilation and renal recovery will be evaluated as secondary analyses.
Sample size: Assuming a CRRT-HI incidence of approximately 50% and an expected AUC of 0.75 for DSI, at least 60 patients are required (α = 0.05, power = 80%). Allowing for approximately 15% data loss, 70 patients will be enrolled.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：mahmut baran kaşısarı, md
- 電話番号：905072225254
- メール：barankasisari@hotmail.com
研究場所
-
-
-
Istanbul、トルコ（Türkiye）
- Basaksehir Cam and Sakura City 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
サンプリング方法
調査対象母集団
Consecutive adult patients (≥18 years) admitted to the general intensive care units of Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey, in whom continuous renal replacement therapy is initiated for acute kidney injury.
説明
Inclusion Criteria:
- Age 18 years or older
- Admission to the general intensive care unit
- Initiation of continuous renal replacement therapy (CRRT) for acute kidney injury
- Standard CRRT indication determined by the attending physician (e.g., uremic complications, refractory fluid overload, hyperkalemia, metabolic acidosis)
- Written informed consent obtained from the patient or legal representative
Exclusion Criteria:
- Pregnancy
- Chronic kidney disease on a maintenance intermittent hemodialysis program before the study
- Significant arrhythmia that may affect diastolic shock index calculation and hemodynamic assessment (e.g., permanent atrial fibrillation, frequent ventricular extrasystoles)
- Permanent discontinuation of CRRT within the first hour due to technical reasons (e.g., catheter dysfunction, circuit clotting)
- Missing or inconsistent data on key hemodynamic parameters
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：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Critically Ill Adults Receiving CRRT
Adult patients (≥18 years) admitted to the general intensive care units of Basaksehir Cam and Sakura City Hospital who are initiated on continuous renal replacement therapy (CRRT) for acute kidney injury. The diastolic shock index (heart rate / diastolic arterial pressure) will be calculated from routine bedside monitoring before and during CRRT, and patients will be followed for the development of CRRT-associated hemodynamic instability. No study-specific intervention will be performed. |
Bedside calculation of the diastolic shock index (heart rate / diastolic arterial pressure) from routine hemodynamic monitoring at CRRT initiation and at 15, 30, 60 and 180 minutes. No additional procedure is performed. |
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 |
|---|---|---|
|
Diagnostic Performance of Pre-CRRT Diastolic Shock Index for Predicting CRRT-Associated Hemodynamic Instability
時間枠：From CRRT initiation to 180 minutes
|
Area under the receiver operating characteristic curve (AUC) of the diastolic shock index (heart rate / diastolic arterial pressure) measured immediately before CRRT initiation for predicting CRRT-associated hemodynamic instability. CRRT-associated hemodynamic instability is defined as at least one of the following: mean arterial pressure <65 mmHg; initiation of a new vasopressor or ≥20% increase in norepinephrine dose; crystalloid fluid bolus >250 mL; or reduction or discontinuation of ultrafiltration. The optimal cut-off value will be determined by the Youden index, with corresponding sensitivity and specificity. |
From CRRT initiation to 180 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of Diastolic Shock Index With Other Bedside Hemodynamic Indices
時間枠：From CRRT initiation to 180 minutes
|
AUC of the diastolic shock index compared with the classic shock index (heart rate / systolic arterial pressure), modified shock index (heart rate / mean arterial pressure) and mean arterial pressure for predicting CRRT-associated hemodynamic instability, compared using the DeLong test. |
From CRRT initiation to 180 minutes
|
|
Incidence of CRRT-Associated Hemodynamic Instability
時間枠：From CRRT initiation to 180 minutes
|
proportion of patients developing CRRT-associated hemodynamic instability as defined in the primary outcome. |
From CRRT initiation to 180 minutes
|
|
28-Day All-Cause Mortality
時間枠：28 days after CRRT initiation
|
All-cause mortality within 28 days of CRRT initiation, compared according to diastolic shock index values and the occurrence of CRRT-associated hemodynamic instability. |
28 days after CRRT initiation
|
協力者と研究者
捜査官
- 主任研究者：mahmut baran kaşısarı, md、Başakşehir Çam & Sakura City Hospital
出版物と役立つリンク
一般刊行物
- Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
- Chazot G, Bitker L, Mezidi M, Chebib N, Chabert P, Chauvelot L, Folliet L, David G, Provoost J, Yonis H, Richard JC. Prevalence and risk factors of hemodynamic instability associated with preload-dependence during continuous renal replacement therapy in a prospective observational cohort of critically ill patients. Ann Intensive Care. 2021 Jun 14;11(1):95. doi: 10.1186/s13613-021-00883-9.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- E-96317027-514.10-321013232
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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。