Colloids in Pediatric Cardiac Surgery: Comparison Between... | NCT02584868

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Volulyte	Experimental	Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)	Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Voluven	Active Comparator	Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)	Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

Name	Type	Description	Arm Group Labels	Other Names
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution	Drug	Peri-operative fluid replacement therapy (max 40ml/kg/day)	Volulyte

Outcomes Module

Measure	Description	Time Frame
Calculated Blood Loss at 3rd Post Operative Day (POD)		72H post surgery

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative Blood Loss	peri-operative blood losses in ml/kg at the end of surgery	End of surgery, an average of 200 minutes
Chest Tube Drainage	Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Philippe Van der Linden, MDPhD	HUDERF	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Universitaire Des Enfants Reine Fabiola		Brussels		1020	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33966019	Derived	Willems A, De Groote F, Schmartz D, Fils JF, Van der Linden P. Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial? Eur J Anaesthesiol. 2021 Sep 1;38(9):923-931. doi: 10.1097/EJA.0000000000001526.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
FG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
BG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00044 BG00144 BG00288

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG00019.9(13.8 to 26.1) OG00115.9(9.0 to 25.3)

Secondary

Intraoperative Blood Loss

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

Posted

Median

Inter-Quartile Range

ml/kg

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Chest Tube Drainage

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

Posted

Mean

Inter-Quartile Range

ml/kg

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Total Blood Loss

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

Posted

Mean

Inter-Quartile Range

ml/kg

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Exposure to Any Blood Products

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

Posted

Count of Participants

Participants

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Exposure to Red Blood Cell

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

Posted

Count of Participants

Participants

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Red Blood Cell Transfused

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

Posted

Median

Inter-Quartile Range

ml/kg

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Exposure to Fresh Frozen Plasma

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

Posted

Count of Participants

Participants

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Fresh Frozen Plasma Transfused

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

Posted

Median

Inter-Quartile Range

ml/kg

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Exposure to Platelets

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

Posted

Count of Participants

Participants

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Platelet Transfused

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

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

Posted

Mean

Standard Deviation

ml/kg

72H post surgery

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Creatinine

Posted

Median

Inter-Quartile Range

mg/dl

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

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044

Secondary

C-Reactive Protein (CRP)

Posted

Median

Inter-Quartile Range

mg/dl

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

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044

Secondary

PTT

Posted

Mean

Standard Deviation

percent

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

APTT

Posted

Mean

Standard Deviation

seconde

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

INR

Posted

Median

Inter-Quartile Range

ratio

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Fibrinogen

Posted

Mean

Standard Deviation

mg/dl

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Clotting Time in Seconds

Clotting time on EXTEM ROTEM®

Posted

Median

Inter-Quartile Range

secondes

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Maximal Cloth Firmness

Maximal cloth firmness on EXTEM ROTEM®

Posted

Median

Inter-Quartile Range

End of surgery, an average of 200 minutes

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG000

Secondary

Creatinine

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

CRP

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

PTT

Posted

Mean

Inter-Quartile Range

percent

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

APTT

Posted

Mean

Inter-Quartile Range

seconde

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

INR

Posted

Mean

Inter-Quartile Range

ratio

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Fibrinogen

Posted

Mean

Standard Deviation

mg/dl

Post-operative Day 1

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Creatinine

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

CRP

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

PTT

Posted

Median

Inter-Quartile Range

percent

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

APTT

Posted

Median

Inter-Quartile Range

seconde

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

INR

Posted

Median

Inter-Quartile Range

ratio

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Fibrinogen

Posted

Mean

Standard Deviation

mg/dl

Post-operative Day 2

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

Creatinine

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 3

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Secondary

CRP

Posted

Median

Inter-Quartile Range

mg/dl

Post-operative Day 3

ID	Title	Description
OG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
OG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)

Units	Counts
Participants	OG00044 OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Saline Colloid	6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)	1	44	1	44	14	44
EG001	Balanced Colloid	6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)	0	44	0	44	10	44

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Heart Failure	Cardiac disorders		Non-systematic Assessment		EG0001 affected44 at risk EG0010 affected44 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0002 affected44 at risk EG0013 affected44 at risk
Convulsion	Nervous system disorders	Non-systematic Assessment	EG0000 affected44 at risk EG0012 affected44 at risk
Hyponatremia (Na<130)	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected44 at risk
Hypernatremia (Na>150)	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected44 at risk EG0013 affected44 at risk
Hyperchloremia (Cl>115)	Metabolism and nutrition disorders	Non-systematic Assessment	EG00010 affected44 at risk EG0012 affected44 at risk

Ancestor Terms

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans
D011134	Polysaccharides
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Term
D006895	Hydroxyethyl Starch Derivatives
D012965	Sodium Chloride
C485123	HES 130-0.4