Trial Outcomes & Findings for Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection (NCT NCT01596283)
NCT ID: NCT01596283
Last Updated: 2017-10-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
30 days post procedure
Results posted on
2017-10-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
66
|
|
Overall Study
COMPLETED
|
69
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Baseline characteristics by cohort
| Measure |
Goal-directed Therapy
n=69 Participants
|
Standard Perioperative Resuscitation
n=66 Participants
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58 years
STANDARD_DEVIATION 14 • n=7 Participants
|
57 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post procedureThe 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.
Outcome measures
| Measure |
Standard Fluid Management
n=66 Participants
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
|
Goal Directed Fluid Therapy
n=69 Participants
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.
|
|---|---|---|
|
Postoperative Complications
30-day survival
|
42 Participants
|
45 Participants
|
|
Postoperative Complications
30-day overall morbidity
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to the first 24 postoperative hoursAssess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively
Outcome measures
| Measure |
Standard Fluid Management
n=66 Participants
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
|
Goal Directed Fluid Therapy
n=69 Participants
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.
|
|---|---|---|
|
Low Cardiac Output Time
|
21 minutes
Standard Deviation 113
|
12 minutes
Standard Deviation 48
|
SECONDARY outcome
Timeframe: Up to the first 72 hours postoperativelyAssess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively
Outcome measures
| Measure |
Standard Fluid Management
n=69 Participants
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
|
Goal Directed Fluid Therapy
n=66 Participants
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.
|
|---|---|---|
|
Total Volume of Fluid Used Perioperatively
|
2.0 liter
Standard Deviation 1.1
|
2.9 liter
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Postoperatively for the total admission time, up to 8 daysPostoperative fluid volume
Outcome measures
| Measure |
Standard Fluid Management
n=69 Participants
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
|
Goal Directed Fluid Therapy
n=66 Participants
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.
|
|---|---|---|
|
Total Volume of Fluid Used Postoperatively
|
0.9 liter
Standard Deviation 0.6
|
1.0 liter
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Postoperatively for the total admission time, up to 8 daysAssess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time
Outcome measures
| Measure |
Standard Fluid Management
n=69 Participants
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
|
Goal Directed Fluid Therapy
n=66 Participants
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.
|
|---|---|---|
|
Postoperative Length of Stay
|
7 days
Interval 6.0 to 8.0
|
6 days
Interval 5.0 to 8.0
|
Adverse Events
Standard Fluid Management
Serious events: 23 serious events
Other events: 66 other events
Deaths: 0 deaths
Goal Directed Fluid Therapy
Serious events: 46 serious events
Other events: 69 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Standard Fluid Management
n=66 participants at risk
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
|
Goal Directed Fluid Therapy
n=69 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Intra-abdominal infection or abscess
|
13.6%
9/66 • 2 years
|
18.8%
13/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.5%
1/66 • 2 years
|
13.0%
9/69 • 2 years
|
|
Infections and infestations
Wound infection
|
1.5%
1/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-infected intra-abdominal/intra-thoracic fluid collection
|
4.5%
3/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Hepatobiliary disorders
Biliary anastomotic leak
|
1.5%
1/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Hepatobiliary disorders
Biloma
|
1.5%
1/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Renal and urinary disorders
Renal Failure
|
1.5%
1/66 • 2 years
|
4.3%
3/69 • 2 years
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
7.6%
5/66 • 2 years
|
11.6%
8/69 • 2 years
|
|
General disorders
Mortality
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
Other adverse events
| Measure |
Standard Fluid Management
n=66 participants at risk
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
|
Goal Directed Fluid Therapy
n=69 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Intra-abdominal infection of abscess
|
15.2%
10/66 • 2 years
|
18.8%
13/69 • 2 years
|
|
Infections and infestations
Wound infection
|
10.6%
7/66 • 2 years
|
7.2%
5/69 • 2 years
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
1.5%
1/66 • 2 years
|
5.8%
4/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-infeccted intra-abdominal/intra-thoracic fluid collection
|
6.1%
4/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Hepatobiliary disorders
Biliary anastomotic leak
|
3.0%
2/66 • 2 years
|
4.3%
3/69 • 2 years
|
|
Hepatobiliary disorders
Biloma
|
1.5%
1/66 • 2 years
|
4.3%
3/69 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/66 • 2 years
|
4.3%
3/69 • 2 years
|
|
Renal and urinary disorders
Renal Failure
|
1.5%
1/66 • 2 years
|
4.3%
3/69 • 2 years
|
|
General disorders
Mortality
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
66/66 • 2 years
|
100.0%
69/69 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
66/66 • 2 years
|
100.0%
69/69 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
66/66 • 2 years
|
100.0%
69/69 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
66/66 • 2 years
|
100.0%
69/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea or Hypoxia
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
4.5%
3/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Injury, poisoning and procedural complications
Bile duct injury
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Bowel perforation, necrosis
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Infections and infestations
Cellulitis
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.5%
1/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
1.5%
1/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Fascial dehiscence or evisceration
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
General disorders
Fever
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Infections and infestations
Foreign body infection
|
0.00%
0/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Infections and infestations
Fungal infection
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Hepatobiliary disorders
Hepatic arterial infusion pump dysfunction
|
3.0%
2/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Ileus, paralytic
|
4.5%
3/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Vascular disorders
Pulmonary embolus
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Injury, poisoning and procedural complications
Splenic injury
|
1.5%
1/66 • 2 years
|
0.00%
0/69 • 2 years
|
|
Cardiac disorders
Supraventricular arrhythmia
|
1.5%
1/66 • 2 years
|
1.4%
1/69 • 2 years
|
|
Vascular disorders
Vascular thrombosis
|
1.5%
1/66 • 2 years
|
2.9%
2/69 • 2 years
|
|
Injury, poisoning and procedural complications
Wound breakdown
|
0.00%
0/66 • 2 years
|
1.4%
1/69 • 2 years
|
Additional Information
Dr. Mary Fischer MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place