Trial Outcomes & Findings for Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (NCT NCT02837731)

NCT ID: NCT02837731

Last Updated: 2020-12-03

Results Overview

Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2020-12-03

Participant Flow

Participant milestones

Measure	Treatment Starling SV Monitor During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.	Usual Care During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.
Allocation STARTED	102	48
Allocation COMPLETED	83	41
Allocation NOT COMPLETED	19	7
Follow-up STARTED	83	41
Follow-up COMPLETED	83	41
Follow-up NOT COMPLETED	0	0
Analysis STARTED	83	41
Analysis COMPLETED	83	41
Analysis NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Treatment Starling SV Monitor During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.	Usual Care During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.
Allocation Admitted to General Floor	3	4
Allocation Immediate surgery/withdrew	2	0
Allocation Diabetic Ketoacidosis/withdrew	1	0
Allocation Withdrawal by Subject	2	0
Allocation Device not available	1	0
Allocation Protocol not implemented	7	0
Allocation Moribund/Do not resuscitate	2	0
Allocation Did not meet sepsis criteria	1	2
Allocation Known aortic abnormalities	0	1

Baseline Characteristics

Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

Baseline characteristics by cohort

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.	Total n=124 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 16.9 • n=5 Participants	62.7 years STANDARD_DEVIATION 15 • n=7 Participants	62.1 years STANDARD_DEVIATION 16.24 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	13 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized White	61 Participants n=5 Participants	31 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: mITT population was predefined as including all patients who signed consent, met study eligibility criteria, were randomized and received monitoring for 72 hours or ICU discharge if earlier. mITT (n=83,41).

Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Fluid Balance	0.65 Liters Standard Deviation 2.85	2.02 Liters Standard Deviation 3.44

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: mITT

Renal replacement therapy (RRT) is therapy that replaces the normal blood-filtering function of the kidneys. It is used when the kidneys are not working well, which is called kidney failure and includes acute kidney injury and chronic kidney disease. Patient receives new treatment with dialysis.

Outcome measures

Measure	Treatment Starling SV Monitor n=79 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=40 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Percentage of Participants Requiring Renal Replacement Therapy	5.1 percentage of participants	17.5 percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: mITT

Patients did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.

Outcome measures

Measure	Treatment Starling SV Monitor n=79 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Percentage of Participants Requiring Ventilator Use	17.7 percentage of participants	34.1 percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: mITT

Intensive Car Unit (ICU) length of stay will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge, or the study exit date.

Outcome measures

Measure	Treatment Starling SV Monitor n=74 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=35 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Length of ICU Stay	3.31 days Standard Deviation 3.51	6.22 days Standard Deviation 10.72

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: mITT

Patients that did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support).

Outcome measures

Measure	Treatment Starling SV Monitor n=14 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=14 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Number of Hours of Ventilator Use	46.99 hours Standard Deviation 52.33	119.42 hours Standard Deviation 134.90

SECONDARY outcome

Timeframe: Day 1 to Day 30

Population: mITT

Vasopressor drugs are provided to restore and maintain blood pressure in patients with septic shock. Patients that have vasopressors initiated throughout the trial are included in this analysis.

Outcome measures

Measure	Treatment Starling SV Monitor n=55 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=26 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Number of Hours of Vasopressor Use	40.74 hours Standard Deviation 51.23	55.64 hours Standard Deviation 87.42

SECONDARY outcome

Timeframe: Baseline, 72 hours

Population: mITT

The diagnosis of Acute Kidney Injury (AKI) is traditionally based on a rise in serum creatinine

Outcome measures

Measure	Treatment Starling SV Monitor n=79 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=34 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Change From Baseline in Serum Creatinine Levels at 72 Hours	0.13 mg/dL Standard Deviation 1.10	0.04 mg/dL Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hours

Population: mITT

Traditional methods of assessing fluid responsiveness (FR) such as vital signs, physical examination, and static measurements of circulatory pressure have shown not to reliably correlate with fluid responsiveness. In contrast, dynamic measurement of stroke volume (SV) following an intravenous (IV) fluid bolus or passive leg raise (PLR) is a safe and feasible method of rapidly assessing the effectiveness of fluid-induced augmentation of SV and cardiac output (CO). Mean volume of treatment fluid Administered (ml) at 72 hours or ICU discharge, whichever occurs first, between the two treatment groups

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Volume of Fluid	5759.2 ml Standard Deviation 2246.8	6865.5 ml Standard Deviation 3348.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

Population: mITT

Incidence of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Percentage of Participants With Major Adverse Cardiac Event (MACE)	6 percentage of participants	12.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

Population: ITT-all randomized.

Adverse events associated with the treatment procedure.

Outcome measures

Measure	Treatment Starling SV Monitor n=102 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=48 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Number of Participants Experiencing an Adverse Event (AE) Related to Study Device	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

Population: mITT

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Percentage of Participants With Hospital Discharge Without ICU Readmission	94.9 percentage of participants	97.8 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

Population: mITT

Incidence of death.

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Percentage of Participants Within Overall 30 Day Mortality Rate	15.7 percentage of participants	22 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

Population: mITT

Patient location (either "home" or "other") following hospital discharge.

Outcome measures

Measure	Treatment Starling SV Monitor n=83 Participants A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=41 Participants No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Number of Participants by Hospital Discharge Location Home	53 Participants	18 Participants
Number of Participants by Hospital Discharge Location Other	30 Participants	23 Participants

Adverse Events

Treatment Starling SV Monitor

Serious events: 10 serious events

Other events: 0 other events

Deaths: 20 deaths

Usual Care

Serious events: 7 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Measure	Treatment Starling SV Monitor n=102 participants at risk A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.	Usual Care n=48 participants at risk No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
Cardiac disorders Cardiac Arrest	2.9% 3/102 • Number of events 3 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	6.2% 3/48 • Number of events 3 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Cardiac disorders Intubation/respiratory distress	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Cardiac disorders Severe septic shock and transition to comfort care	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Intubation and ards	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	2.1% 1/48 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Intubation and surgery	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Hypoxic Respiratory Failure	0.00% 0/102 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	2.1% 1/48 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Respiratory, thoracic and mediastinal disorders Respiratory distress requiring intubation and transfer to ICU	0.00% 0/102 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	2.1% 1/48 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Metabolism and nutrition disorders Multiorgan Failure	0.00% 0/102 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	2.1% 1/48 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.
Skin and subcutaneous tissue disorders Skin tear and possible infection related to the monitor leads	0.98% 1/102 • Number of events 1 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.	0.00% 0/48 • Day 1 to Day 30 It was not pre-specified in the Study Protocol to collect Other (Not Including Serious) Adverse Events. For Mortality and SAE, safety analyses were performed on randomized (ITT) population.

Other adverse events

Adverse event data not reported

Additional Information

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Results disclosure agreements

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