Trial Outcomes & Findings for Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure (NCT NCT01215240)

NCT ID: NCT01215240

Last Updated: 2019-08-02

Results Overview

Time to first post-operative negative fluid balance which occurred in first 72 hrs

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: up to 72 hours
• Results posted on: 2019-08-02

Participant Flow

Participant milestones

Measure	Prophylactic Peritoneal Dialysis A peritoneal dialysis catheter (PDC) was inserted at the time of the Norwood operation. The PDC was left open to drainage until the patient was stable enough to start peritoneal dialysis cycles. Criteria to start PD cycles included: no fluid bolus given within the past four hours; no escalation of inotropes or vasopressors within the last two hours; vasoactive inotropes score (VIS) ≤ 15; and oxygen saturations ≥ 65% on FiO2 ≤ 0.4. PD cycles consisted initially of 10 ml/kg dwell volumes with initial 1.5% dextrose concentration and 60 minute manual cycles (in/dwell 40 minutes, drain 20 minutes).	Standard Care Without PDC This group did not receive a peritoneal dialysis catheter at the time of their Norwood. This group received standard care according to their attending physician. At our institution, diuresis is typically initiated with furosemide, either by continuous infusion or bolus dosing at the discretion of the treating team. Study design allowed for placement of a peritoneal dialysis catheter if clinically indicated due to recalcitrant hyperkalemia (serum potassium \> 5.9 mEq/L), volume overload unresponsive to diuretics, abdominal compartment syndrome, oliguria (urine output \< 1 ml/kg/hr) for more than four hours despite medical intervention or increased serum creatinine in association with persistent metabolic acidosis or low cardiac output syndrome (LCOS).
Overall Study STARTED	10	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

Baseline characteristics by cohort

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants Standard care with diuretics	Total n=22 Participants Total of all reporting groups
Age, Continuous	9.2 Days STANDARD_DEVIATION 4 • n=5 Participants	9.4 Days STANDARD_DEVIATION 5.5 • n=7 Participants	9.3 Days STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 hours

Time to first post-operative negative fluid balance which occurred in first 72 hrs

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Time to First Post-operative Negative 24 Hour Fluid Balance	2.7 Days Standard Deviation 1.06	2.67 Days Standard Deviation 0.65

SECONDARY outcome

Timeframe: Up to 200 hours

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Time to Sternal Closure	5.33 days Standard Deviation 2.87	4.17 days Standard Deviation 1.12

SECONDARY outcome

Timeframe: From time of admission in PICU until assessment was reached, assessed up to 24 hours

Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Time to Lactate Less Than or Equal to 2mmol/L	15.5 Hours Standard Deviation 10.1	20.3 Hours Standard Deviation 8.3

SECONDARY outcome

Timeframe: Up to 15 days

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Time to First Extubation	10.1 days Standard Deviation 4.1	8.6 days Standard Deviation 4.9

SECONDARY outcome

Timeframe: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported

The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5	16.4 score on a scale Standard Deviation 9.8	15.0 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: Assessed up to 8 weeks

Outcome measures

Measure	Prophylactic Peritoneal Dialysis n=10 Participants Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 Participants
Hospital Length of Stay	20.4 days Standard Deviation 10.8	27.7 days Standard Deviation 21.4

Adverse Events

Prophylactic Peritoneal Dialysis

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Standard Care Without PDC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prophylactic Peritoneal Dialysis n=10 participants at risk Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 participants at risk
Cardiac disorders CPR	40.0% 4/10 • Number of events 4	0.00% 0/12
Cardiac disorders ECLS	30.0% 3/10 • Number of events 3	0.00% 0/12

Other adverse events

Measure	Prophylactic Peritoneal Dialysis n=10 participants at risk Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis	Standard Care Without PDC n=12 participants at risk
Renal and urinary disorders Catheter leakage	20.0% 2/10 • Number of events 2	0.00% 0/12
Renal and urinary disorders Retention of PD fluid	40.0% 4/10 • Number of events 4	0.00% 0/12

Additional Information

Dr. Lindsay Ryerson

University of Alberta

Phone: 780 407 3396

Email: ryerson@ualberta.ca

Results disclosure agreements

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