Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

Postoperative Complications Clinical Trial

Official title:

Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687826
• Other study ID #: GDFT1517
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high although the operation techniques have developed a lot in recent years. There is evidence that restrictive intraoperative fluid therapy could decrease postoperative complication rates but the results of the former studies have been somewhat controversial. The aim of this study is to examine whether the intraoperative and postoperative fluid therapy affect to the postoperative complication rates in patients undergoing pancreaticoduodenectomy.

Description:

The study is a retrospective cohort study. The first cohort consists of patients who underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed using goal directed fluid therapy technique. The second cohort consists of patients who underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based on the consideration of the anaesthesiologist. In 2015 most of the patients spent the first postoperative night in the ICU where the fluid management and monitoring of the urine output and vital functions were more controlled than in the normal ward. In 2017 most of the patients got in the regular ward right after the surgery. The aim of the study is to examine whether there are differences in the amounts of the intraoperative and postoperative fluids between the cohorts and does the perioperative fluid therapy affect to the complication rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: November 20, 2020
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 18 or over

• patients who underwent pancreaticoduodenectomy in 2015 or in 2017

Exclusion Criteria:

• patients whose patient record information is insufficient

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• Goal directed fluid therapy
Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.
• Liberal fluid therapy
Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative fluid volume	The amount of fluid (crystalloids and albumin) patients got during the surgery	The duration of the surgery
Primary	Postoperative complications (Clavien-Dindo classification)	The rate of severe Clavien-Dindo complications (3-5)	Postoperative day 0-30
Secondary	Severe surgical complications	The rate of surgical complications (Clavien Dindo 3-5), without cardiopulmonary complications	Postoperative day 0-30
Secondary	Cardiopulmonary complications	The rate of cardiopulmonary complications e.g., congestive heart failure, pleural effusion, dyspnea.	Postoperative day 0-30
Secondary	Pancreatic fistulas	The rate of severe pancreatic fistulas (grade B-C)	Postoperative day 0-30
Secondary	Postoperative fluid volume	The amount of fluid patients got postoperatively	Postoperative day 0-3
Secondary	Intraoperative fluid balance	The change in intraoperative fluid intake (crystalloids, colloids, blood products) and fluid output (urine output, blood loss, evaporation) in millilitres and ml/kg.	The duration of the surgery
Secondary	Postoperative fluid balance	The change in postoperative fluid intake (crystalloids, colloids, blood products) and fluid output (urine output, secretion in drains etc.) in millilitres.	Postoperative day 1-3