PancreaticoduodenectomyPhase 2NCT01428050
The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
A Phase 2 study testing 3% NaCl Solution and Lactated Ringers Solution in people with Pancreaticoduodenectomy, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- 3% NaCl Solution and Lactated Ringers Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2015
- Phase
- Phase 2
- 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
- Physiologic suitability for major abdominal surgery
- Aged 18 years and older
- Written informed consent
- Ability to understand and comply with study guidelines
- Ability to obtain a central venous line
Who cannot join
- Metabolic acidosis
- Active Sepsis or Bacteremia
- Chronic renal insufficiency
- Hyponatremia (serum sodium <130)
- Hypernatremia (serum sodium >150)
- Pregnancy
Show all 9Show fewer
- Sickle cell anemia
- Pediatric patients
- BMI>40
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Harish Lavu, MD, 215-955-9402, Harish.Lavu@jeffersonhospital.org
About this study
Official title: Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- 3% NaCl Solution, Lactated Ringers Solution
- Keywords
- whipple, hypertonic saline, pancreaticoduodenectomy, fluid restriction, resuscitation strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% NaCl SolutionDrug
1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution
Lactated Ringers SolutionDrug
15cc/kg/hr for intraoperative fluids
| Study group | Role | What they receive |
|---|---|---|
| 3% saline | Experimental | Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration Receives: Drug: 3% NaCl Solution |
| Lactated Ringers | Active comparator | 15cc/kg/hr of lactated ringers solution intraoperatively Receives: Drug: Lactated Ringers Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leak
Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy
Measured: 30 days
Delayed Gastric Emptying
Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding
Measured: 30 days
Myocardial Infarction
Measured: 30 days
Pneumonia
Measured: 30 days
Wound Infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harish Lavu, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428050
- Sponsor's protocol ID
- Jefferson Hypertonic
- Status last verified
- Mar 2015
- First submitted
- 31 Aug 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
PubMed 25115420
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01428050
- Acronym / sponsor ID
- Jefferson Hypertonic
- Conditions
- Pancreaticoduodenectomy
- Keywords
- whipple, hypertonic saline, pancreaticoduodenectomy, fluid restriction, resuscitation strategy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Sep 2011 (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.
The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% saline | Experimental | Drug: 3% NaCl SolutionPatients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration |
| Lactated Ringers | Active comparator | Drug: Lactated Ringers Solution15cc/kg/hr of lactated ringers solution intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physiologic suitability for major abdominal surgery
- Aged 18 years and older
- Written informed consent
- Ability to understand and comply with study guidelines
- Ability to obtain a central venous line
Key exclusion criteria (9 listed)
- Metabolic acidosis
- Active Sepsis or Bacteremia
- Chronic renal insufficiency
- Hyponatremia (serum sodium <130)
- Hypernatremia (serum sodium >150)
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 |
|---|---|---|
| 3% NaCl Solution1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution | Drug | 3% saline |
| Lactated Ringers Solution15cc/kg/hr for intraoperative fluids | Drug | Lactated Ringers |
Primary outcome
Anastomotic Leak
Time frame: 30 days
Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy
Delayed Gastric Emptying
Time frame: 30 days
Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding
Myocardial Infarction
Time frame: 30 days
Pneumonia
Time frame: 30 days
Wound Infection
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 25115420Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
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Patients Who Undergo Pancreaticoduodenectomy
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.
Harish Lavu, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3% NaCl Solution and Lactated Ringers Solution in people with Pancreaticoduodenectomy, run by Thomas Jefferson University 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Mar 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harish Lavu, MD (215-955-9402, harish.lavu@jeffersonhospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leak (time frame: 30 days). The study lists 5 primary outcomes in all. 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 NCT01428050, which also lists 1 linked publication.
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 18 Mar 2015.