Postoperative IleusNCT01818375
Goal Directed Fluid Therapy and Postoperative Ileus
A study testing Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided and Standard fluid therapy in people with Postoperative Ileus, run by Gabriele Baldini, MD, MSc, Assistant Professor at 1 site in Canada.
Trial summary
Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided and Standard fluid therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Aug 2015
- 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
- All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program
Who cannot join
- Age <18 yr
- Emergency surgery
- Patients who do not understand, read or communicate in either French or English
- Patients who had undergone esophageal or gastric surgery
- Esophageal pathology (esophageal varices or cancer)
- Patients with coarctation of the aorta or aortic stenosis
- Chronic atrial fibrillation
- 7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial
Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.
It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.
Read the detailed description
Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)
Two arms:
GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.
Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.
ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.
- Conditions
- Postoperative Ileus
- Being tested
- Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided, Standard fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guidedProcedure or surgery
Also called Esophageal doppler-Deltex Medical
Standard fluid therapyOther
Also called Intravenous infusion as recommended by international guidelines and anesthesia text-books
| Study group | Role | What they receive |
|---|---|---|
| Goal Directed Fluid Therapy (GDFT) | Experimental | During surgery, patients in the Goal Directed Fluid Therapy (GDFT) will receive:
1. maintenance infusion of intravenous infusion of ringer lactate at a rate of 1.5 ml/Kg/hr to compensate insensible blood loss and fluid shift during surgery as recommended by perioperative fluid management guidelines for patients undergoing surgery with an enhanced recovery program and receiving a GDFT approach;
2. intraoperative intravenous boluses of colloids (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride-Voluven) guided by an algorithm based on Esophageal Doppler (ED) estimation of the stroke volume (SV) provided by the manufacture, and also used in other clinical trials. Receives: Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided |
| Standard Fluid Therapy | Active comparator | During surgery, patients will receive a maintenance infusion of intravenous infusion of ringer lactate as recommended by international guidelines and anesthesia text-books (Standard Fluid Therapy). In the Standard Fluid Therapy arm, the Esophageal Doppler (ED) monitor will be turned away from the anesthesia care provider, and the screen will be covered with an opaque card. The ED variables will be collected by an independent research personnel. Hemodynamic variables triggering extra fluid administration (Ringer Lactate or Voluven) will be decided based on the clinical judgment of the anesthetist in charge and will include: urinary output less than 0.5/ml/kg/hr, an increase in heart rate more than 20% above baseline or more than 110 beats/min, a decrease in mean systolic blood pressure less than 20% below baseline or less than 90 mmHg and intraoperative blood loss. Boluses of 200 ml of intravenous fluid will be administered until the above targets will be restored Receives: Other: Standard fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary postoperative ileus (POI)
Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported:
- vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (13)
Intraoperative hemodynamic measurements
Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate; flow-time corrected (FTc); stroke distance (SD); Peak velocity (PV); stroke volume (SV); stroke index (SVI); cardiac output (CO); cardiac Index (CI)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and postoperative fluids and blood products required
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Vasoactive agents required
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Urinary output
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and postoperative urinary output
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and Postoperative opioid consumption
Intraoperative opioid administration and postoperative opioid consumption
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Postoperative nausea and vomiting (PONV)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Time spent out of bed
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Postoperative complications (Clavien Classification)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Patients' weight
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Quality of surgical recovery score
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Readiness to be discharged
: according to the colorectal pathway, hospital discharge is planned on postoperative day 3. Patients will be discharged if afebrile, able to tolerate oral diet, pain is controlled (NRS < 4), and able to ambulate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriele Baldini, MD, MSc, Assistant Professor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818375
- Sponsor's protocol ID
- 12-277-SDR
- Status last verified
- Oct 2015
- First submitted
- 21 Mar 2013
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PubMed 12357146Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PubMed 19837807Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.
PubMed 21873370Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
PubMed 23099039Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552.
PubMed 19283742Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
PubMed 23062720
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01818375
- Acronym / sponsor ID
- 12-277-SDR
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Gabriele Baldini, MD, MSc, Assistant ProfessorUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Mar 2013 (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.
Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.
It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.
Detailed description
Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)
Two arms:
GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.
Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.
ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Directed Fluid Therapy (GDFT) | Experimental | Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guidedDuring surgery, patients in the Goal Directed Fluid Therapy (GDFT) will receive: 1. maintenance infusion of intravenous infusion of ringer lactate at a rate of 1.5 ml/Kg/hr to compensate insensible blood loss and fluid shift during surgery as recommended by perioperative fluid management guidelines for patients undergoing surgery with an enhanced recovery program and receiving a GDFT approach; 2. intraoperative intravenous boluses of colloids (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride-Voluven) guided by an algorithm based on Esophageal Doppler (ED) estimation of the stroke volume (SV) provided by the manufacture, and also used in other clinical trials. |
| Standard Fluid Therapy | Active comparator | Other: Standard fluid therapyDuring surgery, patients will receive a maintenance infusion of intravenous infusion of ringer lactate as recommended by international guidelines and anesthesia text-books (Standard Fluid Therapy). In the Standard Fluid Therapy arm, the Esophageal Doppler (ED) monitor will be turned away from the anesthesia care provider, and the screen will be covered with an opaque card. The ED variables will be collected by an independent research personnel. Hemodynamic variables triggering extra fluid administration (Ringer Lactate or Voluven) will be decided based on the clinical judgment of the anesthetist in charge and will include: urinary output less than 0.5/ml/kg/hr, an increase in heart rate more than 20% above baseline or more than 110 beats/min, a decrease in mean systolic blood pressure less than 20% below baseline or less than 90 mmHg and intraoperative blood loss. Boluses of 200 ml of intravenous fluid will be administered until the above targets will be restored |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program
Key exclusion criteria (8 listed)
- Age <18 yr
- Emergency surgery
- Patients who do not understand, read or communicate in either French or English
- Patients who had undergone esophageal or gastric surgery
- Esophageal pathology (esophageal varices or cancer)
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 |
|---|---|---|
| Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guidedAlso: Esophageal doppler-Deltex Medical | Procedure or surgery | Goal Directed Fluid Therapy (GDFT) |
| Standard fluid therapyAlso: Intravenous infusion as recommended by international guidelines and anesthesia text-books | Other | Standard Fluid Therapy |
Primary outcome
Primary postoperative ileus (POI)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported: i. vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet.
13 secondary outcomes
Intraoperative hemodynamic measurements
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and postoperative fluids and blood products required
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Vasoactive agents required
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Urinary output
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and postoperative urinary output
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Intraoperative and Postoperative opioid consumption
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Postoperative nausea and vomiting (PONV)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Time spent out of bed
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Postoperative complications (Clavien Classification)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Patients' weight
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Quality of surgical recovery score
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Readiness to be discharged
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
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 5 Oct 2015.
- Background: PubMed 12357146Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Background: PubMed 19837807Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
- Background: PubMed 21873370Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.
- Background: PubMed 23099039Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
- Background: PubMed 19283742Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552.
- Background: PubMed 23062720Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided and Standard fluid therapy in people with Postoperative Ileus, run by Gabriele Baldini, MD, MSc, Assistant Professor at 1 site in Canada.
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 8 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 5 Oct 2015. 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 Canada. 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?
Primary postoperative ileus (POI) (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days). 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 NCT01818375, which also lists 6 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 5 Oct 2015.