Trial Outcomes & Findings for REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery (NCT NCT02073162)
NCT ID: NCT02073162
Last Updated: 2019-10-31
Results Overview
Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between "disabled" and "not disabled").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3000 participants
Primary outcome timeframe
1 year
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
Liberal Group
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Overall Study
STARTED
|
1499
|
1501
|
|
Overall Study
COMPLETED
|
1493
|
1490
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Total
n=2983 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 13 • n=5 Participants
|
66 years
STANDARD_DEVIATION 13 • n=7 Participants
|
66 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
710 Participants
n=5 Participants
|
719 Participants
n=7 Participants
|
1429 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
783 Participants
n=5 Participants
|
771 Participants
n=7 Participants
|
1554 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
841 Participants
n=5 Participants
|
836 Participants
n=7 Participants
|
1677 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
247 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
134 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
116 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Body Weight
|
83 kg
n=5 Participants
|
84 kg
n=7 Participants
|
83 kg
n=5 Participants
|
|
ASA Physical Status Classification
ASA I
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
ASA Physical Status Classification
ASA II
|
540 Participants
n=5 Participants
|
542 Participants
n=7 Participants
|
1082 Participants
n=5 Participants
|
|
ASA Physical Status Classification
ASA III
|
868 Participants
n=5 Participants
|
849 Participants
n=7 Participants
|
1717 Participants
n=5 Participants
|
|
ASA Physical Status Classification
ASA IV
|
64 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Median preoperative WHODAS score
|
15 units on a scale
n=5 Participants
|
15 units on a scale
n=7 Participants
|
15 units on a scale
n=5 Participants
|
|
Hypertension
|
908 Participants
n=5 Participants
|
899 Participants
n=7 Participants
|
1807 Participants
n=5 Participants
|
|
Coronary artery disease
|
250 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Heart failure
|
47 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Previous myocardial infarction
|
146 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Peripheral vascular disease
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Current smoker
|
204 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
History of stroke or TIA
|
115 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Chronic obstructive pulmonary disease
|
254 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
498 Participants
n=5 Participants
|
|
Moderate or severe renal disease
|
108 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Neuraxial block
|
358 Participants
n=5 Participants
|
409 Participants
n=7 Participants
|
767 Participants
n=5 Participants
|
|
Invasive blood-pressure monitoring
|
1080 Participants
n=5 Participants
|
1070 Participants
n=7 Participants
|
2150 Participants
n=5 Participants
|
|
CVP monitoring
|
272 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Type of Surgery
Esophageal or gastric
|
257 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Type of Surgery
Hepatobiliary
|
139 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Type of Surgery
Colorectal
|
651 Participants
n=5 Participants
|
646 Participants
n=7 Participants
|
1297 Participants
n=5 Participants
|
|
Type of Surgery
Urologic or renal
|
223 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Type of Surgery
Gynecologic
|
139 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Type of Surgery
Other
|
84 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Surgical method
Open
|
788 Participants
n=5 Participants
|
818 Participants
n=7 Participants
|
1606 Participants
n=5 Participants
|
|
Surgical method
Laparoscopic
|
463 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
921 Participants
n=5 Participants
|
|
Surgical method
Laparoscopic-assisted
|
242 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Duration of Surgery
|
3.3 hr
n=5 Participants
|
3.3 hr
n=7 Participants
|
3.3 hr
n=5 Participants
|
|
Planned postoperative care in HDU or ICU
|
418 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
834 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearDisability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between "disabled" and "not disabled").
Outcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Disability-free Survival
|
1232 Participants
|
1223 Participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
72 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: 30-dayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With a Composite of Mortality or Major Septic Complications
|
195 Participants
|
323 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Surgical-site Infection
|
202 Participants
|
245 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Sepsis
|
129 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Anastomotic Leak
|
35 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Pneumonia
|
57 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants Undergoing Renal-replacement Therapy
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Indexed hospital stayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Pulmonary Edema
|
32 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 30 dayOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Number of Participants With Unplanned Admission to ICU
|
145 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Death
|
18 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 12 monthOutcome measures
| Measure |
Liberal Group
n=1493 Participants
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 Participants
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Death
|
96 Participants
|
95 Participants
|
Adverse Events
Liberal Group
Serious events: 103 serious events
Other events: 205 other events
Deaths: 0 deaths
Restrictive Group
Serious events: 118 serious events
Other events: 208 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liberal Group
n=1493 participants at risk
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 participants at risk
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.5%
23/1493
|
0.87%
13/1490
|
|
Vascular disorders
Stroke
|
0.13%
2/1493
|
0.54%
8/1490
|
|
Cardiac disorders
Other cardiovascular
|
3.7%
55/1493
|
4.4%
66/1490
|
|
Vascular disorders
Thromboembolish
|
1.5%
23/1493
|
2.1%
31/1490
|
Other adverse events
| Measure |
Liberal Group
n=1493 participants at risk
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
Restrictive Group
n=1490 participants at risk
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Major Abdominal Surgery: •All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
|
|---|---|---|
|
Blood and lymphatic system disorders
Other
|
13.7%
205/1493
|
14.0%
208/1490
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place