Major Abdominal SurgeryNCT02073162
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
A study testing Major Abdominal Surgery in people with Major Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Major Abdominal Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥18 years) undergoing elective major surgery and providing informed consent
- 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)
- at increased risk of postoperative complications, defined as at least one of the following criteria:
- age ≥70 years
- known or documented history of coronary artery disease
- known or documented history of heart failure
Show all 19Show fewer
- diabetes currently treated with an oral hypoglycaemic agent and/or insulin
- preoperative serum creatinine >200 μmol/L (>2.8 mg/dl)
- morbid obesity (BMI ≥35 kg/m2)
- preoperative serum albumin <30 g/L
- anaerobic threshold (if done) <12 mL/kg/min
- or two or more of the following risk factors:
- ASA 3 or 4
- chronic respiratory disease
- obesity (BMI 30-35 kg/m2)
- aortic or peripheral vascular disease
- preoperative haemoglobin <100 g/L
- preoperative serum creatinine 150-199 μmol/L (>1.7 mg/dl)
- anaerobic threshold (if done) 12-14 mL/kg/min
Who cannot join
- urgent or time-critical surgery
- ASA physical status 5 - such patients are not expected to survive with or without surgery, and their underlying illness is expected to have an overwhelming effect on outcome (irrespective of fluid therapy)
- chronic renal failure requiring dialysis
- pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
- liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
- minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethral resection of the prostate, inguinal hernia repair, splenectomy, closure of colostomy - each of these are typically "minor" surgery with minimal IV fluid requirements, generally low rates of complications and mostly very good survival.
Trial locations and contacts
1 site in 1 country.
About this study
Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery.
Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone.
Read more
Preadmission Clinic/Preoperative Visit
- Sign the consent document
- Have blood drawn for standard preoperative tests (standard of care)
- Have an electrocardiogram (standard of care)
- Complete a questionnaire on disability (research)
Day of Surgery
- Have blood drawn if not already done during the first visit (standard of care)
- Have an electrocardiogram if not already done during the first visit (standard of care)
- Be randomly assigned to either restrictive or liberal fluid management (research)
Post-op Day 1
- Have an electrocardiogram done (research)
- Have blood drawn for standard tests (standard of care)
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Post-op Day 3
- Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research).
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Day of Discharge
- Have a wound inspection, if there is a change of dressing (standard of care) 30-Day Follow-up Phone Call
- Complete a questionnaire about your recovery (research)
- Complete a questionnaire about disability (research) 3 Month, 6-Month, and 12-Month Follow-up Phone Calls
- Complete a questionnaire about disability (research)
- Conditions
- Major Abdominal Surgery
- Being tested
- Major Abdominal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Abdominal SurgeryProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| Liberal group | Active comparator | 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 Receives: Procedure: Major Abdominal Surgery |
| Restrictive group | Experimental | 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 Receives: Procedure: Major Abdominal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Disability-free Survival
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").
Measured: 1 year
Secondary outcomes (11)
Number of Participants With Acute Kidney Injury
Measured: 90 days
Number of Participants With a Composite of Mortality or Major Septic Complications
Measured: 30-day
Number of Participants With Surgical-site Infection
Measured: Indexed hospital stay
Number of Participants With Sepsis
Measured: Indexed hospital stay
Number of Participants With Anastomotic Leak
Measured: Indexed hospital stay
Number of Participants With Pneumonia
Measured: Indexed hospital stay
Number of Participants Undergoing Renal-replacement Therapy
Measured: Indexed hospital stay
Number of Participants With Pulmonary Edema
Measured: Indexed hospital stay
Number of Participants With Unplanned Admission to ICU
Measured: 30 day
Death
Measured: 90 days
Death
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Kurz, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073162
- Sponsor's protocol ID
- 13-1287
- Status last verified
- Oct 2019
- First submitted
- 21 Feb 2014
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02073162
- Acronym / sponsor ID
- 13-1287
- Conditions
- Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery.
Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone.
Preadmission Clinic/Preoperative Visit
- Sign the consent document
- Have blood drawn for standard preoperative tests (standard of care)
- Have an electrocardiogram (standard of care)
- Complete a questionnaire on disability (research)
Day of Surgery
- Have blood drawn if not already done during the first visit (standard of care)
- Have an electrocardiogram if not already done during the first visit (standard of care)
- Be randomly assigned to either restrictive or liberal fluid management (research)
Post-op Day 1
- Have an electrocardiogram done (research)
- Have blood drawn for standard tests (standard of care)
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Post-op Day 3
- Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research).
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Day of Discharge
- Have a wound inspection, if there is a change of dressing (standard of care) 30-Day Follow-up Phone Call
- Complete a questionnaire about your recovery (research)
- Complete a questionnaire about disability (research) 3 Month, 6-Month, and 12-Month Follow-up Phone Calls
- Complete a questionnaire about disability (research)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal group | Active comparator | Procedure: Major Abdominal SurgeryAt 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 |
| Restrictive group | Experimental | Procedure: Major Abdominal SurgeryAt 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- adults (≥18 years) undergoing elective major surgery and providing informed consent
- 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)
- at increased risk of postoperative complications, defined as at least one of the following criteria:
- age ≥70 years
- known or documented history of coronary artery disease
Key exclusion criteria (6 listed)
- urgent or time-critical surgery
- ASA physical status 5 - such patients are not expected to survive with or without surgery, and their underlying illness is expected to have an overwhelming effect on outcome (irrespective of fluid therapy)
- chronic renal failure requiring dialysis
- pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
- liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Liberal group, Restrictive group |
Primary outcome
Number of Participants With Disability-free Survival
Time frame: 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").
11 secondary outcomes
Number of Participants With Acute Kidney Injury
Time frame: 90 days
Number of Participants With a Composite of Mortality or Major Septic Complications
Time frame: 30-day
Number of Participants With Surgical-site Infection
Time frame: Indexed hospital stay
Number of Participants With Sepsis
Time frame: Indexed hospital stay
Number of Participants With Anastomotic Leak
Time frame: Indexed hospital stay
Number of Participants With Pneumonia
Time frame: Indexed hospital stay
Number of Participants Undergoing Renal-replacement Therapy
Time frame: Indexed hospital stay
Number of Participants With Pulmonary Edema
Time frame: Indexed hospital stay
Number of Participants With Unplanned Admission to ICU
Time frame: 30 day
Death
Time frame: 90 days
Death
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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AI-Assisted Education Before Surgery to Prevent Lung Complications in Older Surgical Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kurz principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Major Abdominal Surgery in people with Major Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Disability-free Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.