Bowel SurgeryNCT00456703
Restricted Fluid Regimen in Open Abdominal Bowel Surgery
A study testing intraoperative fluid management and fluid restriction in people with Bowel Surgery, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Surgery
- What is being tested?
- intraoperative fluid management and fluid restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2009
- 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
- ASA physical status I-III patients coming in for open abdominal bowel surgery
Who cannot join
- Coagulopathy,
- Pregnancy,
- Renal insufficiency,
- Contraindications for placing a central line,
- ASA IV and V,
- Age less than 18years
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery
Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery.
Read the detailed description
This is a randomized, prospective controlled trial in patients (ASA I-III) undergoing open abdominal surgical procedures in a single center. This study will be done in two phases. The first phase is designed to evaluate and prove the safety of restricted fluid regimens in maintaining tissue perfusion using a central venous oximetric catheter and arterial blood gas analysis. In the second phase of the study, we plan to mimic the usual clinical practice without the central venous oximetric catheter and arterial lines (invasive monitors) and the postoperative total morbidity will be compared between the liberal and restricted fluid regimens.
In the first phase of the study, 90 patients coming in for open bowel surgery will be randomized to three groups using a random number generator. All patients will receive a standard bowel prep regimen (Go-Lyte-half a liter the night before surgery). Group A will receive current standard of care (liberal fluid therapy), Group B and C will receive restricted fluid regimens. All patients will receive 500 cc of intravenous fluids (lactated ringers in Group A and B, 6% hetastarch in Group C) in the preoperative holding area to correct preoperative fluid deficits due to fasting and bowel preparation. Patients younger than 18 years, ASA IV or V, pregnant patients, those with coagulopathy, renal insufficiency, unstable angina, unstable congestive heart failure, and those with contraindication to central venous pressure catheter insertion will be excluded from the study.
After instituting anesthesia monitors, patients will be anesthetized with a standard anesthetic regimen. An arterial line and a central venous catheter with oximetric capability will be inserted in all three groups. A baseline blood gas will be drawn to note the base excess, lactate levels and the hematocrit at the start of surgery. Parameters like heart rate, blood pressure, central venous pressure, mixed venous oxygen saturation and arterial oxygen saturation and urine output will be continuously monitored. Both the regimens will be started in the operating room and continued into the postoperative period until they resume their oral intake. Patients in the liberal group will receive (10ml/kg/hr) the current standard of care for bowel surgery whereas those in the restricted group will receive 4ml/kg/hour. Post induction hemodynamic instability will be treated with ephedrine and phenylephrine at the discretion of the anesthesiologist in charge.
Intraoperative treatment of tachycardia, hypotension in both the groups will be treated using a standard fluid regimen algorithm (appendix A). All patients will receive the same postoperative fluid regimens as the current standard of care. Postoperative morbidity evaluation (appendix B) will be done at patient's discharge from the hospital. The data entry will be prospectively done during their hospital stay. The accuracy of the data will be checked by one of the study investigators.
- Conditions
- Bowel Surgery
- Being tested
- intraoperative fluid management, fluid restriction
- Keywords
- fluids,, restriction,, infection,, bowel surgery,, open abdominal
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative fluid managementOther
fluid restriction
fluid restrictionOther
restriction of fluids
| Study group | Role | What they receive |
|---|---|---|
| restriction | Active comparator | In this group, the fluids will be restricted compared to a standard procedure Receives: Other: intraoperative fluid management; Other: fluid restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
mixed venous oxygen saturation, acid bases, hemodynamics
Measured: intraoperative period
Secondary outcomes (1)
Wound infection and length of hospital stay
Measured: during the hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startJul 2008
- Primary completionJul 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bowel SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456703
- Sponsor's protocol ID
- 2006P000144
- Status last verified
- Mar 2017
- First submitted
- 4 Apr 2007
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.
PubMed 15983453Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery
- ClinicalTrials.gov ID
- NCT00456703
- Acronym / sponsor ID
- 2006P000144
- Conditions
- Bowel Surgery
- Keywords
- fluids,, restriction,, infection,, bowel surgery,, open abdominal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 5 Apr 2007 (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.
Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery.
Detailed description
This is a randomized, prospective controlled trial in patients (ASA I-III) undergoing open abdominal surgical procedures in a single center. This study will be done in two phases. The first phase is designed to evaluate and prove the safety of restricted fluid regimens in maintaining tissue perfusion using a central venous oximetric catheter and arterial blood gas analysis. In the second phase of the study, we plan to mimic the usual clinical practice without the central venous oximetric catheter and arterial lines (invasive monitors) and the postoperative total morbidity will be compared between the liberal and restricted fluid regimens.
In the first phase of the study, 90 patients coming in for open bowel surgery will be randomized to three groups using a random number generator. All patients will receive a standard bowel prep regimen (Go-Lyte-half a liter the night before surgery). Group A will receive current standard of care (liberal fluid therapy), Group B and C will receive restricted fluid regimens. All patients will receive 500 cc of intravenous fluids (lactated ringers in Group A and B, 6% hetastarch in Group C) in the preoperative holding area to correct preoperative fluid deficits due to fasting and bowel preparation. Patients younger than 18 years, ASA IV or V, pregnant patients, those with coagulopathy, renal insufficiency, unstable angina, unstable congestive heart failure, and those with contraindication to central venous pressure catheter insertion will be excluded from the study.
After instituting anesthesia monitors, patients will be anesthetized with a standard anesthetic regimen. An arterial line and a central venous catheter with oximetric capability will be inserted in all three groups. A baseline blood gas will be drawn to note the base excess, lactate levels and the hematocrit at the start of surgery. Parameters like heart rate, blood pressure, central venous pressure, mixed venous oxygen saturation and arterial oxygen saturation and urine output will be continuously monitored. Both the regimens will be started in the operating room and continued into the postoperative period until they resume their oral intake. Patients in the liberal group will receive (10ml/kg/hr) the current standard of care for bowel surgery whereas those in the restricted group will receive 4ml/kg/hour. Post induction hemodynamic instability will be treated with ephedrine and phenylephrine at the discretion of the anesthesiologist in charge.
Intraoperative treatment of tachycardia, hypotension in both the groups will be treated using a standard fluid regimen algorithm (appendix A). All patients will receive the same postoperative fluid regimens as the current standard of care. Postoperative morbidity evaluation (appendix B) will be done at patient's discharge from the hospital. The data entry will be prospectively done during their hospital stay. The accuracy of the data will be checked by one of the study investigators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| restriction | Active comparator | Other: intraoperative fluid management, Other: fluid restrictionIn this group, the fluids will be restricted compared to a standard procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-III patients coming in for open abdominal bowel surgery
Key exclusion criteria (6 listed)
- Coagulopathy,
- Pregnancy,
- Renal insufficiency,
- Contraindications for placing a central line,
- ASA IV and V,
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 |
|---|---|---|
| intraoperative fluid managementfluid restriction | Other | restriction |
| fluid restrictionrestriction of fluids | Other | restriction |
Primary outcome
mixed venous oxygen saturation, acid bases, hemodynamics
Time frame: intraoperative period
1 secondary outcome
Wound infection and length of hospital stay
Time frame: during the hospital admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Background: PubMed 15983453Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
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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.
Balachundhar Subramaniam, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative fluid management and fluid restriction in people with Bowel Surgery, run by Beth Israel Deaconess Medical Center 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 1 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: withdrawn, as of the sponsor's last update on 6 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 was withdrawn before enrolling participants, so there are no results.
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?
mixed venous oxygen saturation, acid bases, hemodynamics (time frame: intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456703, which also lists 2 linked publications.
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 6 Mar 2017.