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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Lactated Ringers | Active Comparator | 15cc/kg/hr of lactated ringers solution intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% NaCl Solution | Drug | 1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leak | Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy | 30 days |
| Delayed Gastric Emptying | Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding | 30 days |
| Myocardial Infarction | 30 days | |
| Pneumonia | 30 days | |
| Wound Infection | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harish Lavu, MD | Contact | 215-955-9402 | harish.lavu@jeffersonhospital.org |
| Name | Affiliation | Role |
|---|---|---|
| Harish Lavu, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25115420 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 20, 2022 | |
| Reset | Feb 8, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2022 | Feb 8, 2022 |
| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lactated Ringers Solution |
| Drug |
15cc/kg/hr for intraoperative fluids |
|