Trial · NCT02073162
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
NCT02073162, Not applicable, Completed, The Cleveland Clinic; results first posted 2019-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery. Trials, record NCT02073162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02073162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
- NCT number
- NCT02073162
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,000 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Major Abdominal Surgery
- Interventions
- Major Abdominal Surgery
- First posted
- 2014-02-27
- Last updated
- 2019-10-31
- Results first posted
- 2019-10-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disability-free Survival | 1 year | 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"). |
| Secondary | Number of Participants With Acute Kidney Injury | 90 days | |
| Secondary | Number of Participants With a Composite of Mortality or Major Septic Complications | 30-day | |
| Secondary | Number of Participants With Surgical-site Infection | Indexed hospital stay | |
| Secondary | Number of Participants With Sepsis | Indexed hospital stay | |
| Secondary | Number of Participants With Anastomotic Leak | Indexed hospital stay | |
| Secondary | Number of Participants With Pneumonia | Indexed hospital stay | |
| Secondary | Number of Participants Undergoing Renal-replacement Therapy | Indexed hospital stay | |
| Secondary | Number of Participants With Pulmonary Edema | Indexed hospital stay | |
| Secondary | Number of Participants With Unplanned Admission to ICU | 30 day |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Disability-free Survival | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Acute Kidney Injury | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Composite of Mortality or Major Septic Complications | 30-day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Surgical-site Infection | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Sepsis | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Anastomotic Leak | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Pneumonia | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Undergoing Renal-replacement Therapy | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Pulmonary Edema | Indexed hospital stay | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Unplanned Admission to ICU | 30 day | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Disability-free Survival | Liberal Group | 1232 | Participants | ||
| Number of Participants With Disability-free Survival | Restrictive Group | 1223 | Participants | ||
| Number of Participants With Acute Kidney Injury | Liberal Group | 72 | Participants | ||
| Number of Participants With Acute Kidney Injury | Restrictive Group | 124 | Participants | ||
| Number of Participants With a Composite of Mortality or Major Septic Complications | Liberal Group | 195 | Participants | ||
| Number of Participants With a Composite of Mortality or Major Septic Complications | Restrictive Group | 323 | Participants | ||
| Number of Participants With Surgical-site Infection | Liberal Group | 202 | Participants | ||
| Number of Participants With Surgical-site Infection | Restrictive Group | 245 | Participants | ||
| Number of Participants With Sepsis | Liberal Group | 129 | Participants | ||
| Number of Participants With Sepsis | Restrictive Group | 157 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liberal Group | 1,499 | |
| Overall Study | STARTED | Restrictive Group | 1,501 | |
| Overall Study | COMPLETED | Liberal Group | 1,493 | |
| Overall Study | COMPLETED | Restrictive Group | 1,490 | |
| Overall Study | NOT COMPLETED | Liberal Group | 6 | |
| Overall Study | NOT COMPLETED | Restrictive Group | 11 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other | Blood and lymphatic system disorders | Liberal Group | 205 | 1,493 | |
| other | Other | Blood and lymphatic system disorders | Restrictive Group | 208 | 1,490 | |
| serious | Myocardial infarction | Cardiac disorders | Liberal Group | 23 | 1,493 | |
| serious | Myocardial infarction | Cardiac disorders | Restrictive Group | 13 | 1,490 | |
| serious | Stroke | Vascular disorders | Liberal Group | 2 | 1,493 | |
| serious | Stroke | Vascular disorders | Restrictive Group | 8 | 1,490 | |
| serious | Other cardiovascular | Cardiac disorders | Liberal Group | 55 | 1,493 | |
| serious | Other cardiovascular | Cardiac disorders | Restrictive Group | 66 | 1,490 | |
| serious | Thromboembolish | Vascular disorders | Liberal Group | 23 | 1,493 | |
| serious | Thromboembolish | Vascular disorders | Restrictive Group | 31 | 1,490 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liberal Group | ||
| Total, all-cause mortality | Restrictive Group | ||
| Total, other adverse events | Liberal Group | 205 | 1,493 |
| Total, other adverse events | Restrictive Group | 208 | 1,490 |
| Total, serious adverse events | Liberal Group | 103 | 1,493 |
| Total, serious adverse events | Restrictive Group | 118 | 1,490 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Liberal Group vs Restrictive Group: Number of Participants With Disability-free Survival | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With a Composite of Mortality or Major Septic Complications | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants Undergoing Renal-replacement Therapy | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Acute Kidney Injury | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Unplanned Admission to ICU | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Surgical-site Infection | Trial comparisons |
| Liberal Group vs Restrictive Group: Death | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Sepsis | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Pneumonia | Trial comparisons |
| Liberal Group vs Restrictive Group: Number of Participants With Anastomotic Leak | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02073162
GET https://conductscience.org/api/trials/v1/NCT02073162/results?page=2