Trial Outcomes & Findings for Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration (NCT NCT01706497)

NCT ID: NCT01706497

Last Updated: 2019-05-15

Results Overview

Defined according to the Kidney Disease: Improving Global Outcome criteria (AKI stage 2 or 3) * serum creatinine (SCr) level ≥ 2 times the baseline level, or * urine output (UO) \< 0.5 ml/kg/hour for ≥ 12 hours, or * provision of dialysis

• Recruitment status: COMPLETED
• Target enrollment: 300 participants
• Primary outcome timeframe: Predictive window of 6 hours before AKI occurence
• Results posted on: 2019-05-15

Participant Flow

In this prospective observational cohort study, we had aimed at including 300 patients with continuous NIRS monitoring in place. In only 177 patients we could retrieve a continuous near-infrared spectroscopy monitoring signal of sufficient quality for inclusion in the study.

Participant milestones

Measure	Post-cardiac Surgery PICU Admissions Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Overall Study STARTED	177
Overall Study COMPLETED	177
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Post-cardiac Surgery PICU Admissions n=177 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Age, Continuous	4 Months n=177 Participants
Sex: Female, Male Female	70 Participants n=177 Participants
Sex: Female, Male Male	107 Participants n=177 Participants
Region of Enrollment Belgium	177 participants n=177 Participants
Weight	5.2 Kilogram n=177 Participants
Cyanotic Heart Defect Post Surgery	70 Participants n=177 Participants
Number of patients on extracorporeal membrane oxygenation (ECMO)	8 Participants n=177 Participants
CPB duration	84.5 Minutes n=177 Participants
Delay between PICU admission and NIRS monitoring start	1.1 Minutes n=177 Participants

PRIMARY outcome

Timeframe: Predictive window of 6 hours before AKI occurence

Population: Of the 177 patients included, 21 patients were excluded: * 4 had AKI within 6 hours after admission * 16 were monitored with NIRS after AKI onset * NIRS monitoring was initiated later than 72 hours in 1 patient, which prevented the fit of prediction time for this patient

Defined according to the Kidney Disease: Improving Global Outcome criteria (AKI stage 2 or 3)

• serum creatinine (SCr) level ≥ 2 times the baseline level, or
• urine output (UO) < 0.5 ml/kg/hour for ≥ 12 hours, or
• provision of dialysis

Outcome measures

Measure	Post-cardiac Surgery PICU Admissions n=156 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs	55 Participants

SECONDARY outcome

Timeframe: Hospital discharge

participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

Outcome measures

Measure	Post-cardiac Surgery PICU Admissions n=177 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Hospital Length of Stay	10 days Interval 6.0 to 21.0

SECONDARY outcome

Timeframe: Intensive care unit discharge

participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

Outcome measures

Measure	Post-cardiac Surgery PICU Admissions n=177 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Intensive Care Unit Length of Stay	4 days Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: ICU discharge

participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

Outcome measures

Measure	Post-cardiac Surgery PICU Admissions n=177 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Duration of Mechanical Ventilation	111.3 hours Interval 69.3 to 190.4

SECONDARY outcome

Timeframe: Hospital discharge

participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

Outcome measures

Measure	Post-cardiac Surgery PICU Admissions n=177 Participants Children after cardiac surgery, younger than 12 years old, with an arterial catheter in place, mechanically ventilated upon PICU admission or intubated after admission, and expected to stay at least 24 hours in the PICU, were included in the study.
Hospital Mortality	9 Participants

Adverse Events

Post-cardiac Surgery PICU Admissions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Dr Geert Meyfroidt, Associate Professor

University Hospitals Leuven (UZ Leuven) and KU Leuven

Phone: 0032 16 344021

Email: geert.meyfroidt@uzleuven.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place