Trial · NCT01424150

REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study

NCT01424150, Not applicable, Completed, Bayside Health; results first posted 2025-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study. Trials, record NCT01424150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01424150

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study
NCT number: NCT01424150
Status: Completed
Phases: Not applicable
Enrollment: 3,000 participants, actual
Lead sponsor: Bayside Health
Conditions: Abdominal Surgery
Interventions: Liberal fluid therapy, Restrictive fluid therapy
First posted: 2011-08-26
Last updated: 2026-01-20
Results first posted: 2025-01-24

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disability-free Survival	1 year postoperative	Disability-free survival up to 1 year: survival and freedom from disability. The latter is defined as a persistent (≥6 months) reduction in health status as measured by a 12-item version (12-60 points) of World Health Organisation Disability Assessment Schedule score (WHODAS) of 24 points, reflecting a disability level of at least 25% and being the threshold point between "disabled" and "not disabled" as per WHO guidelines. Disability will be assessed by the participant, but if unable then we will use the proxy's report. The date of onset of new disability will be recorded. Further details are provided in the Procedures Manual and the Statistical Analysis Plan.
Secondary	Death	90 days, then up to 12 months after surgery	deceased within 12 months
Secondary	Composite Septic Outcome or Death	30 days postoperative	composite of 1 or more of:sepsis, surgical site infection, anastomotic leak, death and pneumonia
Secondary	Sepsis	30 days postoperative	using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria, two or more features of the systematic inflammatory response syndrome (SIRS) plus evidence of a source or site of infection (can be positive blood culture or purulence from any site)
Secondary	Surgical Site Infection	30 days postoperative	using CDC criteria (http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf):
Secondary	Pneumonia	30 Days postoperative	The presence of new and/or progressive pulmonary infiltrates on chest radiograph plus two or more of the following: 1. Fever ≥ 38.5°C or postoperative hypothermia \<36°C 2. Leukocytosis ≥ 12,000 WBC/mm3 or leukopenia \< 4,000 WBC/mm3 3. Purulent sputum and/or 4. New onset or worsening cough or dyspnoea.
Secondary	Acute Kidney Injury	30 days postoperative	according to The Kidney Disease: Improving Global Outcomes (KDIGO) group criteria, but not urine output - for Stage 2 or worse AKI defined as at least 2-fold increase in creatinine, or estimated GFR decrease \>50%.(73) We also plan to report renal replacement therapy up to 90 days after surgery. Because a restrictive IV fluid regimen may artificially elevate serum creatinine due to a smaller dilutional effect from less IV fluids, we therefore calculated adjusted creatinine by first estimating the volume of distribution for creatinine as equal to total body water (assumed to be 60% of body weight, expressed in mL).
Secondary	Pulmonary Oedema	30 days postoperative	respiratory distress or impaired oxygenation AND radiological evidence of pulmonary oedema
Secondary	Total Duration of Time Spend in the ICU or HDU (in Days)	30 day postoperative	including initial ICU admission and readmission times up to 30 days post operatively
Secondary	Hospital Stay	30 days postoperative	from the start (date, time) of surgery until actual hospital discharge

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Disability-free Survival	1 year postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Death	90 days, then up to 12 months after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Composite Septic Outcome or Death	30 days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Sepsis	30 days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Surgical Site Infection	30 days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pneumonia	30 Days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Acute Kidney Injury	30 days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pulmonary Oedema	30 days postoperative	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Duration of Time Spend in the ICU or HDU (in Days)	30 day postoperative	days	MEDIAN
SECONDARY	Hospital Stay	30 days postoperative	days	MEDIAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Disability-free Survival	Liberal	165	Participants
Disability-free Survival	Restrictive	172	Participants
Death	Liberal	96	Participants
Death	Restrictive	95	Participants
Composite Septic Outcome or Death	Liberal	295	Participants
Composite Septic Outcome or Death	Restrictive	323	Participants
Sepsis	Liberal	129	Participants
Sepsis	Restrictive	157	Participants
Surgical Site Infection	Liberal	245	Participants
Surgical Site Infection	Restrictive	202	Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Liberal	1,501
Overall Study	STARTED	Restrictive	1,499
Overall Study	COMPLETED	Liberal	1,493
Overall Study	COMPLETED	Restrictive	1,490
Overall Study	NOT COMPLETED	Liberal	8
Overall Study	NOT COMPLETED	Restrictive	9

Source ClinicalTrials.gov

Adverse events12

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	Cardiovascular	Cardiac disorders	Liberal	78	1,493	78
other	Cardiovascular	Cardiac disorders	Restrictive	79	1,490	79
other	Thrombolism	Blood and lymphatic system disorders	Liberal	23	1,493	23
other	Thrombolism	Blood and lymphatic system disorders	Restrictive	31	1,490	31
serious	Surgical site infection	Infections and infestations	Liberal	295	1,493	295
serious	Surgical site infection	Infections and infestations	Restrictive	323	1,490	323
serious	Sepsis	Infections and infestations	Liberal	129	1,493	129
serious	Sepsis	Infections and infestations	Restrictive	157	1,490	157
serious	Anastomotic leak	Infections and infestations	Liberal	35	1,493	35
serious	Anastomotic leak	Infections and infestations	Restrictive	49	1,490	49

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liberal	96	1,493
Total, all-cause mortality	Restrictive	95	1,490
Total, other adverse events	Liberal	78	1,493
Total, other adverse events	Restrictive	79	1,490
Total, serious adverse events	Liberal	295	1,493
Total, serious adverse events	Restrictive	323	1,490

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28259855	DERIVED	PubMed
29742967	DERIVED	PubMed
30916001	DERIVED	PubMed
31774526	DERIVED	PubMed
33521643	DERIVED	PubMed
42331645	DERIVED	PubMed

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 comparisons11

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Liberal vs Restrictive: Death	Trial comparisons
Liberal vs Restrictive: Sepsis	Trial comparisons
Liberal vs Restrictive: Acute Kidney Injury	Trial comparisons
Liberal vs Restrictive: Pulmonary Oedema	Trial comparisons
Liberal vs Restrictive: Pneumonia	Trial comparisons
Liberal vs Restrictive: Anastomotic Leak	Trial comparisons
Liberal vs Restrictive: Composite Septic Outcome or Death	Trial comparisons
Liberal vs Restrictive: Surgical Site Infection	Trial comparisons
Liberal vs Restrictive: Disability-free Survival	Trial comparisons
Liberal vs Restrictive: deaths from any cause	Trial comparisons

1 to 10 of 11

See all 11 trial comparisons

Tests0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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