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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: mahmut baran kaşısarı, md
- Numer telefonu: 905072225254
- E-mail: barankasisari@hotmail.com
Lokalizacje studiów
-
-
-
Istanbul, Turcja (Türkiye)
- Basaksehir Cam and Sakura City Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diagnostic Performance of Pre-CRRT Diastolic Shock Index for Predicting CRRT-Associated Hemodynamic Instability
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Comparison of Diastolic Shock Index With Other Bedside Hemodynamic Indices
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: mahmut baran kaşısarı, md, Başakşehir Çam & Sakura City Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby naczyniowe
- Choroby układu krążenia
- Procesy patologiczne
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Atrybuty choroby
- Niewydolność nerek
- Stany patologiczne, oznaki i objawy
- Śmiertelna choroba
- Ostre uszkodzenie nerek
- Niedociśnienie
Inne numery identyfikacyjne badania
- E-96317027-514.10-321013232
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .