Trial Outcomes & Findings for Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid (NCT NCT02584868)

NCT ID: NCT02584868

Last Updated: 2020-11-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: 72H post surgery
• Results posted on: 2020-11-09

Participant Flow

Participant milestones

Measure	Saline Colloid 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Overall Study STARTED	44	44
Overall Study COMPLETED	44	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	44 Participants n=44 Participants	44 Participants n=44 Participants	88 Participants n=88 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=88 Participants
Age, Categorical >=65 years	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=88 Participants
Age, Continuous	6.3 Months n=44 Participants	6.9 Months n=44 Participants	6.6 Months n=88 Participants
Sex: Female, Male Female	24 Participants n=44 Participants	18 Participants n=44 Participants	42 Participants n=88 Participants
Sex: Female, Male Male	20 Participants n=44 Participants	26 Participants n=44 Participants	46 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	44 Participants n=44 Participants	44 Participants n=44 Participants	88 Participants n=88 Participants

PRIMARY outcome

Timeframe: 72H post surgery

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Calculated Blood Loss at 3rd Post Operative Day (POD)	19.9 ml/kg Interval 13.8 to 26.1	15.9 ml/kg Interval 9.0 to 25.3

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

peri-operative blood losses in ml/kg at the end of surgery

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Intraoperative Blood Loss	4.7 ml/kg Interval 2.8 to 7.2	4.8 ml/kg Interval 2.9 to 6.4

SECONDARY outcome

Timeframe: 72H post surgery

Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Chest Tube Drainage	18.8 ml/kg Interval 11.8 to 27.7	18.8 ml/kg Interval 14.8 to 28.3

SECONDARY outcome

Timeframe: 72H post surgery

Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Total Blood Loss	25.7 ml/kg Interval 18.7 to 34.0	23.4 ml/kg Interval 18.4 to 34.1

SECONDARY outcome

Timeframe: 72H post surgery

Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Exposure to Any Blood Products	36 Participants	30 Participants

SECONDARY outcome

Timeframe: 72H post surgery

Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Exposure to Red Blood Cell	35 Participants	30 Participants

SECONDARY outcome

Timeframe: 72H post surgery

Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=35 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=30 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Red Blood Cell Transfused	21.9 ml/kg Interval 18.4 to 38.5	26.1 ml/kg Interval 15.7 to 44.4

SECONDARY outcome

Timeframe: 72H post surgery

Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Exposure to Fresh Frozen Plasma	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 72H post surgery

Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=4 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=4 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Fresh Frozen Plasma Transfused	12.6 ml/kg Interval 9.3 to 46.4	12.2 ml/kg Interval 10.1 to 26.8

SECONDARY outcome

Timeframe: 72H post surgery

Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Exposure to Platelets	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 72H post surgery

Population: No platelet transfusion performed in subjects enrolled in the balanced colloid group

Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

Outcome measures

Measure	Saline Colloid n=2 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Platelet Transfused	13.7 ml/kg Standard Deviation 6.4	—

SECONDARY outcome

Timeframe: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Creatinine	0.28 mg/dl Interval 0.24 to 0.33	0.29 mg/dl Interval 0.25 to 0.36

SECONDARY outcome

Timeframe: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
C-Reactive Protein (CRP)	5.0 mg/dl Interval 1.4 to 5.0	5.0 mg/dl Interval 1.8 to 5.0

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
PTT	52.1 percent Standard Deviation 9.4	50.1 percent Standard Deviation 10.4

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
APTT	39.4 seconde Standard Deviation 5.8	38.6 seconde Standard Deviation 5.0

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
INR	1.5 ratio Interval 1.4 to 1.7	1.5 ratio Interval 1.4 to 1.7

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Fibrinogen	159.0 mg/dl Standard Deviation 51.0	148.0 mg/dl Standard Deviation 38.0

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Clotting time on EXTEM ROTEM®

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Clotting Time in Seconds	90.5 secondes Interval 72.8 to 111.3	88.0 secondes Interval 59.0 to 103.5

SECONDARY outcome

Timeframe: End of surgery, an average of 200 minutes

Maximal cloth firmness on EXTEM ROTEM®

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Maximal Cloth Firmness	50.0 mm Interval 42.8 to 55.0	48.0 mm Interval 42.0 to 52.5

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Creatinine	0.33 mg/dl Interval 0.24 to 0.46	0.30 mg/dl Interval 0.26 to 0.42

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
CRP	31.3 mg/dl Interval 23.5 to 45.0	39.5 mg/dl Interval 25.8 to 56.0

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
PTT	87.5 percent Interval 75.0 to 96.8	81.0 percent Interval 71.0 to 99.0

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
APTT	31.2 seconde Interval 28.9 to 35.7	34.7 seconde Interval 31.1 to 38.9

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
INR	1.1 ratio Interval 1.0 to 1.2	1.1 ratio Interval 1.0 to 1.2

SECONDARY outcome

Timeframe: Post-operative Day 1

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Fibrinogen	345.0 mg/dl Standard Deviation 83.0	365.0 mg/dl Standard Deviation 94.0

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Creatinine	0.29 mg/dl Interval 0.22 to 0.34	0.27 mg/dl Interval 0.22 to 0.33

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
CRP	41.0 mg/dl Interval 23.2 to 55.6	43.5 mg/dl Interval 27.4 to 65.3

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
PTT	86.0 percent Interval 72.0 to 96.0	80.5 percent Interval 71.8 to 97.5

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
APTT	31.5 seconde Interval 28.7 to 35.7	33.2 seconde Interval 29.2 to 36.7

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
INR	1.1 ratio Interval 1.0 to 1.2	1.1 ratio Interval 1.0 to 1.2

SECONDARY outcome

Timeframe: Post-operative Day 2

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Fibrinogen	346.2 mg/dl Standard Deviation 82.2	352.6 mg/dl Standard Deviation 90.5

SECONDARY outcome

Timeframe: Post-operative Day 3

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Creatinine	0.25 mg/dl Interval 0.18 to 0.32	0.24 mg/dl Interval 0.19 to 0.29

SECONDARY outcome

Timeframe: Post-operative Day 3

Outcome measures

Measure	Saline Colloid n=44 Participants 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 Participants 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
CRP	33.0 mg/dl Interval 22.0 to 53.7	29.6 mg/dl Interval 19.8 to 49.5

Adverse Events

Saline Colloid

Serious events: 1 serious events

Other events: 14 other events

Deaths: 1 deaths

Balanced Colloid

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Saline Colloid n=44 participants at risk 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 participants at risk 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Cardiac disorders Heart Failure	2.3% 1/44 • through study completion, an average of 14 days	0.00% 0/44 • through study completion, an average of 14 days

Other adverse events

Measure	Saline Colloid n=44 participants at risk 6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	Balanced Colloid n=44 participants at risk 6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
Renal and urinary disorders Renal failure	4.5% 2/44 • through study completion, an average of 14 days	6.8% 3/44 • through study completion, an average of 14 days
Nervous system disorders Convulsion	0.00% 0/44 • through study completion, an average of 14 days	4.5% 2/44 • through study completion, an average of 14 days
Metabolism and nutrition disorders Hyponatremia (Na<130)	2.3% 1/44 • through study completion, an average of 14 days	0.00% 0/44 • through study completion, an average of 14 days
Metabolism and nutrition disorders Hypernatremia (Na>150)	2.3% 1/44 • through study completion, an average of 14 days	6.8% 3/44 • through study completion, an average of 14 days
Metabolism and nutrition disorders Hyperchloremia (Cl>115)	22.7% 10/44 • through study completion, an average of 14 days	4.5% 2/44 • through study completion, an average of 14 days

Additional Information

Philippe Van der Linden, MD, PhD

Centre Hospitalier Universitaire Brugmann

Phone: +32 2 477 23 30

Email: philippe.vanderlinden@chu-brugmann.be

Results disclosure agreements

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