Clinical Trial of Standard Versus Goal-Directed Periopera... | NCT01596283

Label	Type	Description	Intervention Names
Standard fluid management	Active Comparator	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.	Procedure: Standard fluid management
Goal directed fluid therapy	Active Comparator	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.	Device: Goal directed fluid therapy with the Edwards EV1000 system

Name	Type	Description	Arm Group Labels	Other Names
Standard fluid management	Procedure	The patient will receive standard fluid management	Standard fluid management

Measure	Description	Time Frame
Postoperative Complications	The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.	30 days post procedure

Measure	Description	Time Frame
Low Cardiac Output Time	Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively	Up to the first 24 postoperative hours
Total Volume of Fluid Used Perioperatively

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (18 years old or greater) who are able to provide informed consent.
Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Exclusion Criteria:

Active coronary disease.
Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
Active symptomatic cerebrovascular disease.
Active congestive heart failure and ejection fraction <35%.
Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.
Active renal dysfunction (Cr >1.8)
Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count < 100,000 per mcL)
Presence of active infection including HIV
Patients with active atrial fibrillation or flutter.
Preoperative hypoalbuminemia (Albumin < 2g/dl).
Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery).
Presence of ascites.
BMI > 45 or <17

Name	Affiliation	Role
Mary Fischer, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

PubMed Identifier	Type	Citation	Retractions
26206652	Derived	Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.

Label	URL
Memorial Sloan Kettering Cancer Center	View source

ID	Title	Description
FG000	Goal-directed Therapy (GDT) After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 28, 2013

ID	Title	Description
BG000	Goal-directed Therapy
BG001	Standard Perioperative Resuscitation
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00069 BG00166 BG002135

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Postoperative Complications

The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.

Posted

Count of Participants

Participants

30 days post procedure

ID	Title	Description
OG000	Standard Fluid Management	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Standard fluid management: The patient will receive standard fluid management
OG001	Goal Directed Fluid Therapy	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system.

Units	Counts
Participants	OG00066 OG00169

Title

Denominators

Categories

Title	Measurements
30-day survival	OG00042 OG00145
30-day overall morbidity	OG000

Secondary

Low Cardiac Output Time

Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively

Posted

Mean

Standard Deviation

minutes

Up to the first 24 postoperative hours

ID	Title	Description
OG000	Standard Fluid Management	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Standard fluid management: The patient will receive standard fluid management
OG001	Goal Directed Fluid Therapy	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system.

Units	Counts
Participants

Secondary

Total Volume of Fluid Used Perioperatively

Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively

Posted

Mean

Standard Deviation

liter

Up to the first 72 hours postoperatively

ID	Title	Description
OG000	Goal-directed Therapy (GDT) After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
OG001	Standard Perioperative Resuscitation After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Units	Counts
Participants	OG000

Secondary

Total Volume of Fluid Used Postoperatively

Postoperative fluid volume

Posted

Mean

Standard Deviation

liter

Postoperatively for the total admission time, up to 8 days

ID	Title	Description
OG000	Goal-directed Therapy (GDT) After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
OG001	Standard Perioperative Resuscitation After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Units	Counts
Participants	OG000

Secondary

Postoperative Length of Stay

Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time

Posted

Median

Full Range

days

Postoperatively for the total admission time, up to 8 days

ID	Title	Description
OG000	Goal-directed Therapy (GDT) After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
OG001	Standard Perioperative Resuscitation After Liver Resection	Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard Fluid Management	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Standard fluid management: The patient will receive standard fluid management	0	66	23	66	66	66
EG001	Goal Directed Fluid Therapy	Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system.	3	69	46	69	69	69

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Intra-abdominal infection or abscess	Infections and infestations	Systematic Assessment	EG0009 affected66 at risk EG00113 affected69 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0019 affected69 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0001 affected66 at risk EG0011 affected69 at risk
Liver dysfunction/failure	Hepatobiliary disorders	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Non-infected intra-abdominal/intra-thoracic fluid collection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected66 at risk EG0010 affected69 at risk
Biliary anastomotic leak	Hepatobiliary disorders	Systematic Assessment	EG0001 affected66 at risk EG0012 affected69 at risk
Biloma	Hepatobiliary disorders	Systematic Assessment	EG0001 affected66 at risk EG0012 affected69 at risk
Hemorrhage	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0001 affected66 at risk EG0013 affected69 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 affected66 at risk EG0012 affected69 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0005 affected66 at risk EG0018 affected69 at risk
Mortality	General disorders	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Thromboembolic Event	Vascular disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Intra-abdominal infection of abscess	Infections and infestations	Systematic Assessment	EG00010 affected66 at risk EG00113 affected69 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0007 affected66 at risk EG0015 affected69 at risk
Liver dysfunction/failure	Hepatobiliary disorders	Systematic Assessment	EG0001 affected66 at risk EG0014 affected69 at risk
Non-infeccted intra-abdominal/intra-thoracic fluid collection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected66 at risk EG0010 affected69 at risk
Biliary anastomotic leak	Hepatobiliary disorders	Systematic Assessment	EG0002 affected66 at risk EG0013 affected69 at risk
Biloma	Hepatobiliary disorders	Systematic Assessment	EG0001 affected66 at risk EG0013 affected69 at risk
Hemorrhage	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected66 at risk EG0013 affected69 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0001 affected66 at risk EG0013 affected69 at risk
Mortality	General disorders	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00066 affected66 at risk EG00169 affected69 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00066 affected66 at risk EG00169 affected69 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00066 affected66 at risk EG00169 affected69 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG00066 affected66 at risk EG00169 affected69 at risk
Apnea or Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0003 affected66 at risk EG0012 affected69 at risk
Bile duct injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Bowel perforation, necrosis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Catheter related infection	Infections and infestations	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0011 affected69 at risk
Clostridium difficile colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0011 affected69 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Fascial dehiscence or evisceration	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Fever	General disorders	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Foreign body infection	Infections and infestations	Systematic Assessment	EG0000 affected66 at risk EG0012 affected69 at risk
Fungal infection	Infections and infestations	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Hepatic arterial infusion pump dysfunction	Hepatobiliary disorders	Systematic Assessment	EG0002 affected66 at risk EG0011 affected69 at risk
Ileus, paralytic	Gastrointestinal disorders	Systematic Assessment	EG0003 affected66 at risk EG0012 affected69 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Pulmonary embolus	Vascular disorders	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk
Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Small bowel obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Splenic injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected66 at risk EG0010 affected69 at risk
Supraventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 affected66 at risk EG0011 affected69 at risk
Vascular thrombosis	Vascular disorders	Systematic Assessment	EG0001 affected66 at risk EG0012 affected69 at risk
Wound breakdown	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected66 at risk EG0011 affected69 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D008107	Liver Diseases