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临床试验/NCT05729048
NCT05729048撤回不适用

Starling Continuous Renal Replacement Therapy (CRRT) Observational Study

Baxter Healthcare Corporation1 个研究点 分布在 1 个国家开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in stroke volume index (SVI) after fluid removal

研究概览

简要总结

Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regard to the patient's fluid status and management of additional fluids and medications.

As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.

This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring during CRRT therapy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 to 95 years of age.
  • Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
  • Hemodynamic monitoring was completed no earlier than 2018

排除标准

  • Patients did not have an arterial line in place during CRRT treatment
  • Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD)
  • Patients with end-stage kidney disease on chronic dialysis
  • Hemodynamic monitoring with Starling did not occur during CRRT treatment
  • Data from Starling, CRRT machine, or arterial line cannot be retrieved

结局指标

主要结局

Change in stroke volume index (SVI) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in stroke volume (SV) after CRRT initiation

时间窗: Day 1 (during CRRT)

Change in cardiac index (CI) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in cardiac output (CO) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in heart rate (HR) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in central venous pressure (CVP) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Changes in systolic blood pressure (SBP) from beginning to end of CRRT

时间窗: Day 1 (Begin CRRT) through Day 1 (End of CRRT)

Changes in diastolic blood pressure (DBP) from beginning to end of CRRT

时间窗: Day 1 (Begin CRRT) through Day 1 (End of CRRT)

Change in stroke volume (SV) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in Thoracic Fluid Content (TFC) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in mixed venous oxygen saturation (SVO2) after fluid removal

时间窗: Day 1 (during CRRT)

Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)

Changes in mean arterial pressure (MAP) from beginning to end of CRRT

时间窗: Day 1 (Begin CRRT) through Day 1 (End of CRRT)

Change in systolic blood pressure (SBP) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in diastolic blood pressure (DBP) after fluid removal

时间窗: Day 1 (during CRRT)

Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)

Change in lactate after fluid removal

时间窗: Day 1 (during CRRT)

Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)

次要结局

  • Incidence of intradialytic hypotension (IDH) free time during CRRT(Day 1 (during CRRT))
  • Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT(Day 1 (during CRRT))
  • Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT(Day 1 (during CRRT))
  • CRRT dose/modality(Day 1 (during CRRT))
  • Changes in hourly/daily fluid balance during CRRT(Day 1 (during CRRT))
  • Changes in cumulative fluid balance during CRRT(Day 1 (during CRRT))
  • Changes in percent fluid overload during CRRT(Day 1 (during CRRT))
  • Incidence of intradialytic hypotension (IDH) during CRRT(Day 1 (during CRRT))
  • Incidence of ultrafiltration failure during CRRT(Day 1 (during CRRT))
  • Blood flow rate during CRRT(Day 1 (during CRRT))
  • Changes in intake and output (I/O) during CRRT(Day 1 (during CRRT))
  • Estimate the contribution degree of certain patient conditions, clinical characteristics, fluid, and CRRT parameters in predicting the IDH risk during CRRT(Day 1 (during CRRT))
  • Identify sub-phenotypes of patients at risk of IDH during CRRT(Day 1 (during CRRT))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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