Benign Neoplasm of Intestinal TractNCT01563991
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes
A study testing Normal fluid volume and Reduced fluid volume in people with Benign Neoplasm of Intestinal Tract and Primary Malignant Neoplasm of Intestinal Tract, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neoplasm of Intestinal Tract, Primary Malignant Neoplasm of Intestinal Tract, Secondary Malignant Neoplasm of Intestinal Tract
- What is being tested?
- Normal fluid volume and Reduced fluid volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to 18 Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients 18 years or older
- ASA I-III
- Ability to provide informed consent
- Creatinine less than or equal to 1.3 mg/mL)
Who cannot join
- Patients younger than 18 years old
- ASA IV or higher
- Urgent or emergent surgery
- Mental disease or addictive disorders impairing ability to provide informed consent
- Renal insufficiency (Cr greater than 1.3 mg/mL)
- Significant language barriers
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- Cirrhosis causing ascites
- NYHA III or IV, EF less than 25%
- Use of intraoperative epidural anesthesia
- Uncontrolled diabetes
- Uncontrolled hypertension in the opinion of the enrolling surgeon
- ETOH consumption greater than 35 drinks weekly
- Cachexia or absolute neutrophil count of less than 1,200/mm3
- Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.
Read the detailed description
The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.
- Conditions
- Benign Neoplasm of Intestinal Tract, Primary Malignant Neoplasm of Intestinal Tract, Secondary Malignant Neoplasm of Intestinal Tract
- Being tested
- Normal fluid volume, Reduced fluid volume
- Keywords
- surgery, fluid, morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal fluid volumeProcedure or surgery
Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
Reduced fluid volumeProcedure or surgery
Subject receives 80 cc/ hr LR during the peri-operative period
| Study group | Role | What they receive |
|---|---|---|
| Standard fluid volume | Active comparator | Subject receives normal fluid volume during peri-operative period Receives: Procedure: Normal fluid volume |
| Reduced Fluid Volume | Experimental | Subject receives a reduced fluid volume during the peri-operative period Receives: Procedure: Reduced fluid volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Reduction in post-operative complications at the time of hospital discharge after the surgical episode
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2007
- Primary completion18 Apr 2012
- Study completion18 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neoplasm of Intestinal TractStudies 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
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Stocchi, The Cleveland Clinic
- Investigators
- Lucci Stocchi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563991
- Sponsor's protocol ID
- 07-016
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01563991
- Acronym / sponsor ID
- 07-016
- Conditions
- Benign Neoplasm of Intestinal Tract, Primary Malignant Neoplasm of Intestinal Tract, Secondary Malignant Neoplasm of Intestinal Tract
- Keywords
- surgery, fluid, morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- 18 Apr 2012 (actual)
- Study completion
- 18 Apr 2012 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.
Detailed description
The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard fluid volume | Active comparator | Procedure: Normal fluid volumeSubject receives normal fluid volume during peri-operative period |
| Reduced Fluid Volume | Experimental | Procedure: Reduced fluid volumeSubject receives a reduced fluid volume during the peri-operative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older
- ASA I-III
- Ability to provide informed consent
- Creatinine less than or equal to 1.3 mg/mL)
Key exclusion criteria (14 listed)
- Patients younger than 18 years old
- ASA IV or higher
- Urgent or emergent surgery
- Mental disease or addictive disorders impairing ability to provide informed consent
- Renal insufficiency (Cr greater than 1.3 mg/mL)
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 |
|---|---|---|
| Normal fluid volumeNormal fluid group will receive lactated ringes at 8 cc / Kg/ hr total | Procedure or surgery | Standard fluid volume |
| Reduced fluid volumeSubject receives 80 cc/ hr LR during the peri-operative period | Procedure or surgery | Reduced Fluid Volume |
Primary outcome
Morbidity
Time frame: 5-7 days
Reduction in post-operative complications at the time of hospital discharge after the surgical episode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Lucci Stocchi, MD 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 Normal fluid volume and Reduced fluid volume in people with Benign Neoplasm of Intestinal Tract and Primary Malignant Neoplasm of Intestinal Tract, 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 4 inclusion and 14 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 30 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morbidity (time frame: 5-7 days). 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 30 Mar 2017.