Trial Outcomes & Findings for PPV to Guide Fluid Management in the PICU (NCT NCT02308371)

NCT ID: NCT02308371

Last Updated: 2017-01-02

Results Overview

Total fluid (ml/kg/day) given during the first 48 hours of enrollment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: First 48 hours after enrollment
• Results posted on: 2017-01-02

Participant Flow

Prospective subjects were considered for enrollment if less than 17 years of age and admitted to the pediatric critical care unit. In addition subjects had to require conventional mechanical ventilation and have an arterial line. Prospective recruitment time between 11/26/2014 and 3/1/2016.

Prospective subjects per the protocol were allowed more than one enrollment on the study during the same admission once recruited. There were 46 unique prospective subjects with 50 enrollments and 50 retrospective enrollments. Numbers below and throughout the results section represent number of enrollments or participation.

Participant milestones

Measure	Prospective Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV\> 13. Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours.	Retrospective Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PPV to Guide Fluid Management in the PICU

Baseline characteristics by cohort

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV\> 13 (in addition to standard clinical data) until PPV \< 13. Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours.	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.	Total n=100 Participants Total of all reporting groups
Age, Continuous	4.099 years STANDARD_DEVIATION 5.765 • n=5 Participants	4.144 years STANDARD_DEVIATION 5.828 • n=7 Participants	4.121 years STANDARD_DEVIATION 5.738 • n=5 Participants
Gender Female	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Gender Male	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Diagnosis Primary Respiratory Failure	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Diagnosis Sepsis	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Diagnosis Diabetic Ketoacidosis	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Diagnosis Persistent Pulmonary Hypertension of the Newborn	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Diagnosis Neuroblastoma	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Diagnosis Spinal Fusion	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Diagnosis Craniotomy	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Diagnosis Congenital Diaphragmatic Hernia	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Diagnosis Congenital Cardiac Disease	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Diagnosis Cerebral Edema	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: First 48 hours after enrollment

Total fluid (ml/kg/day) given during the first 48 hours of enrollment

Outcome measures

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Total Fluid (ml/kg/Day) Given	124.38 ml/kg/day Standard Deviation 63.05	122.099 ml/kg/day Standard Deviation 50.27

PRIMARY outcome

Timeframe: 48 hours after enrollment

Total fluid bolused within 48 hours after enrollment.

Outcome measures

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Total Fluid Bolused	11.55 ml/kg Standard Deviation 16.34	28.08 ml/kg Standard Deviation 56.60

SECONDARY outcome

Timeframe: From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment

Outcome measures

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Number of Hours on Vasopressors	71.74 hours Standard Deviation 123	42.4 hours Standard Deviation 63.2

SECONDARY outcome

Timeframe: From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy

Outcome measures

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Number of Days on Ventilatory Support	23.8 days Standard Deviation 45.6	8.68 days Standard Deviation 9.7

SECONDARY outcome

Timeframe: From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)

Outcome measures

Measure	Prospective n=50 Participants Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective n=50 Participants Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Number of Days in the PICU	28.66 days Standard Deviation 36.64	12.48 days Standard Deviation 11.85

Adverse Events

Prospective

Serious events: 22 serious events

Other events: 0 other events

Deaths: 0 deaths

Retrospective

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prospective n=50 participants at risk Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).	Retrospective Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
Investigations Death	10.0% 5/50 • Number of events 5 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.	— 0/0 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.
Investigations Extracorporeal Life Support	4.0% 2/50 • Number of events 2 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.	— 0/0 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.
Respiratory, thoracic and mediastinal disorders Prolonged Intubation	28.0% 14/50 • Number of events 14 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.	— 0/0 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.
Renal and urinary disorders Fluid Overload	6.0% 3/50 • Number of events 3 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.	— 0/0 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.
Renal and urinary disorders Renal Failure	4.0% 2/50 • Number of events 2 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.	— 0/0 • Adverse events were recorded until subjects discharge from the pediatric critical care unit. There was no recording or evaluation of adverse events in the retrospective group since they were evaluated retrospectively. The adverse events recorded are more likely secondary to the critically ill nature of the cohort rather than PPV itself.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Hines

University of North Carolina

Phone: 901-652-6138

Email: mhinesthomas@gmail.com

Results disclosure agreements

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