Postoperative ComplicationsNCT04687826
Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy
An observational study of Postoperative Complications, run by Helsinki University Central Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Goal directed fluid therapy and Liberal fluid therapy
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 20 Nov 2020
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted in the study.
Who may be able to join
- age 18 or over
- patients who underwent pancreaticoduodenectomy in 2015 or in 2017
Who cannot join
- patients whose patient record information is insufficient
About this study
Official title: Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications
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.
Read the detailed 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.
- Conditions
- Postoperative Complications
- Being tested
- Goal directed fluid therapy, Liberal fluid therapy
- Keywords
- pancreaticoduodenectomy, Clavien-Dindo classification, pancreatic fistulas
- Medical subject headings
- Postoperative Complications, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed fluid therapyOther
Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.
Liberal fluid therapyOther
Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticoduodenectomy in 2015 | Patients who underwent pancreaticoduodenectomy in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique. Most of the patients spent the first postoperative night in ICU where the monitoring of urine output and fluid balance are more specific than in a normal ward. Receives: Other: Goal directed fluid therapy | |
| Pancreaticoduodenectomy in 2017 | Patients who underwent pancreaticoduodenectomy in 2017 got liberal intraoperative fluid therapy and most of the patients spent the first postoperative night in a regular ward. Receives: Other: Liberal fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fluid volume
The amount of fluid (crystalloids and albumin) patients got during the surgery
Measured: The duration of the surgery
Postoperative complications (Clavien-Dindo classification)
The rate of severe Clavien-Dindo complications (3-5)
Measured: Postoperative day 0-30
Secondary outcomes (6)
Severe surgical complications
The rate of surgical complications (Clavien Dindo 3-5), without cardiopulmonary complications
Measured: Postoperative day 0-30
Cardiopulmonary complications
The rate of cardiopulmonary complications e.g., congestive heart failure, pleural effusion, dyspnea.
Measured: Postoperative day 0-30
Pancreatic fistulas
The rate of severe pancreatic fistulas (grade B-C)
Measured: Postoperative day 0-30
Postoperative fluid volume
The amount of fluid patients got postoperatively
Measured: Postoperative day 0-3
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.
Measured: The duration of the surgery
Postoperative fluid balance
The change in postoperative fluid intake (crystalloids, colloids, blood products) and fluid output (urine output, secretion in drains etc.) in millilitres.
Measured: Postoperative day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piia Peltoniemi, Helsinki University Central Hospital
- Investigators
- Piia Peltoniemi, M.D., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687826
- Sponsor's protocol ID
- GDFT1517
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications
- ClinicalTrials.gov ID
- NCT04687826
- Acronym / sponsor ID
- GDFT1517
- Conditions
- Postoperative Complications
- Keywords
- pancreaticoduodenectomy, Clavien-Dindo classification, pancreatic fistulas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 29 Dec 2020 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticoduodenectomy in 2015 | – | Other: Goal directed fluid therapyPatients who underwent pancreaticoduodenectomy in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique. Most of the patients spent the first postoperative night in ICU where the monitoring of urine output and fluid balance are more specific than in a normal ward. |
| Pancreaticoduodenectomy in 2017 | – | Other: Liberal fluid therapyPatients who underwent pancreaticoduodenectomy in 2017 got liberal intraoperative fluid therapy and most of the patients spent the first postoperative night in a regular ward. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted in the study.
Key inclusion criteria (2 listed)
- age 18 or over
- patients who underwent pancreaticoduodenectomy in 2015 or in 2017
Key exclusion criteria (1 listed)
- patients whose patient record information is insufficient
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 therapyPatients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique. | Other | Pancreaticoduodenectomy in 2015 |
| Liberal fluid therapyPatients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist. | Other | Pancreaticoduodenectomy in 2017 |
Primary outcome
Intraoperative fluid volume
Time frame: The duration of the surgery
The amount of fluid (crystalloids and albumin) patients got during the surgery
Postoperative complications (Clavien-Dindo classification)
Time frame: Postoperative day 0-30
The rate of severe Clavien-Dindo complications (3-5)
6 secondary outcomes
Severe surgical complications
Time frame: Postoperative day 0-30
Cardiopulmonary complications
Time frame: Postoperative day 0-30
Pancreatic fistulas
Time frame: Postoperative day 0-30
Postoperative fluid volume
Time frame: Postoperative day 0-3
Intraoperative fluid balance
Time frame: The duration of the surgery
Postoperative fluid balance
Time frame: Postoperative day 1-3
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 29 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Piia Peltoniemi, M.D. principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Helsinki University Central Hospital.
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 2 inclusion and 1 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 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraoperative fluid volume (time frame: The duration of the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2020.