Starling/CRRT Observational Study

Withdrawn

• Conditions: Hemodynamic Monitoring
• Interventions: Device: Starling

• Registration Number: NCT05729048
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14
• Study Start: 2023-07-15
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. ≥18 to 95 years of age.
2. Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
3. Hemodynamic monitoring was completed no earlier than 2018

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodynamic Monitoring	Starling	Over the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor during CRRT treatment.

Primary Outcome Measures

Name	Time	Method
Change in stroke volume index (SVI) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in stroke volume (SV) after CRRT initiation	Day 1 (during CRRT)
Change in cardiac index (CI) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in cardiac output (CO) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in heart rate (HR) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in central venous pressure (CVP) after fluid removal	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	Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Changes in diastolic blood pressure (DBP) from beginning to end of CRRT	Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Change in stroke volume (SV) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in Thoracic Fluid Content (TFC) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in mixed venous oxygen saturation (SVO2) after fluid removal	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	Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Change in systolic blood pressure (SBP) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in diastolic blood pressure (DBP) after fluid removal	Day 1 (during CRRT)	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in lactate after fluid removal	Day 1 (during CRRT)	Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)

Secondary Outcome Measures

Name	Time	Method
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)	Fluid balance parameter
Incidence of intradialytic hypotension (IDH) during CRRT	Day 1 (during CRRT)
Incidence of ultrafiltration failure during CRRT	Day 1 (during CRRT)	Including prescribed/archived, time to fluid balance
Blood flow rate during CRRT	Day 1 (during CRRT)
Changes in intake and output (I/O) during CRRT	Day 1 (during CRRT)	Fluid balance parameter
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)

Trial Locations

Locations (1)

Baxter Investigational Site; 🇺🇸 Lexington, Kentucky, United States