Effect of Ascites Replacement Strategy on Time to 1st Fla... | NCT04184401

NCT04184401

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
GC Pharma	UNKNOWN

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
Replacement with albumin	Experimental	Check drain amount every 4 hour after SICU admission Replacement of 70% of drainage from previous 4 hours over next 4 hours 30% of the drainage with 5% albumin 40% of drainage with Hartmann's solution If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin	Drug: Ascites replacement with albumin and hartmann's solution
Replacement with Hartmann's solution	Active Comparator	Check drain amount every 4 hour after SICU admission Replacement of 70% of drainage from previous 4 hours with Hartmann's solution over next 4 hours If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin	Drug: Ascites replacement with hartmann's solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ascites replacement with albumin and hartmann's solution	Drug	Combined strategy for ascites replacement 30% of ascites: replacement with 5% albumin 40% of ascites: replacement with Hartmann's solution

Outcomes Module

Measure	Description	Time Frame
Time to 1st flatus	Interval between SICU admission and 1st flatus	within 4 weeks
Time to 1st diet	Interval between SICU admission and 1st diet	within 4 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ho Geol Ryu, MD, PhD	Seoul National University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D001201	Ascites

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D000418	Albumins
D000077325	Ringer's Lactate

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions