Fluid TherapyNCT03553394
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
A study testing Ringer's Acetate in people with Fluid Therapy and Postoperative Period, run by Uppsala University at 1 site in Sweden.
Trial summary
Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Therapy, Postoperative Period, Postoperative Complications
- What is being tested?
- Ringer's Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2018to 30 Aug 2022
- 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
- Patients going through pancreatic surgery.
Who cannot join
- If not oliguric (urinary output <0,5 mls/kg/h) during their stay in the postoperative department
- Hemodynamic instability (the need for >0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).
- Patients that do not want to be a part of the study.
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects on Fluid Balance and Renal Function Using a Restrictive Fluid Strategy in the Postoperative Setting in Patients With Low Urinary Output Undergoing Pancreatic Surgery
Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. The aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.
Read the detailed description
Patents after pancreatic surgery will be included in the study. Oliguric patients (urine output <0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg Ringer's Acetate in 30 minutes) or no intervention. Primary outcome is difference in urine output two hours after the fluid bolus or no intervention.
- Conditions
- Fluid Therapy, Postoperative Period, Postoperative Complications, Pancreas Disease, Fluid Overload
- Being tested
- Ringer's Acetate
- Medical subject headings
- Postoperative Complications, Pancreatic Diseases, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's AcetateDrug
Also called Ringer Acetate
Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | Active comparator | Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care). Receives: Drug: Ringer's Acetate |
| Expectant management group | No intervention | Await fluid therapy for 2 hours. Will NOT receive a fluid bolus if oliguric/anuric for two consecutive hours and a now assessment will be made after two more hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary output
Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..
Measured: 2 hours
Secondary outcomes (8)
Renal function
Renal function after 48 hours
Measured: 48 hours
Cumulative fluid balance
Difference in cumulative fluid balance
Measured: 48 hours
Postoperative complications
Frequency of postoperative complications in both groups
Measured: 90 days
Renal replacement therapy
The need for renal replacement therapy during the hospital stay
Measured: Up to 90 days
Mortality
90-day mortality in both groups
Measured: 90 days
Inotropy
Postoperative need of inotropic therapy during the stay in the postoperative department
Measured: 1 week
Vasopressin (ADH)
Levels of vasopressin in serum immediately before and after the operation
Measured: 1 day
S-osmolality
S-osmolality immediately before and after the operation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Oct 2018
- Primary completion31 May 2021
- Study completion30 Aug 2022
Why it stopped: Stopped after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Uppsala 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either receive a fluid bolus immediately when urinary output is decreased for two consecutive hours or to await fluid bolus therapy for two more hours.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miklos Lipcsey, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553394
- Sponsor's protocol ID
- 2018/147
- Status last verified
- Oct 2022
- First submitted
- 23 May 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Fluid Balance and Renal Function Using a Restrictive Fluid Strategy in the Postoperative Setting in Patients With Low Urinary Output Undergoing Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03553394
- Acronym / sponsor ID
- 2018/147
- Conditions
- Fluid Therapy, Postoperative Period, Postoperative Complications, Pancreas Disease, Fluid Overload
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped after interim analysis
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Jun 2018 (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.
Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. The aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.
Detailed description
Patents after pancreatic surgery will be included in the study. Oliguric patients (urine output <0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg Ringer's Acetate in 30 minutes) or no intervention. Primary outcome is difference in urine output two hours after the fluid bolus or no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either receive a fluid bolus immediately when urinary output is decreased for two consecutive hours or to await fluid bolus therapy for two more hours.
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | Active comparator | Drug: Ringer's AcetateWill receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care). |
| Expectant management group | No intervention | –Await fluid therapy for 2 hours. Will NOT receive a fluid bolus if oliguric/anuric for two consecutive hours and a now assessment will be made after two more hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients going through pancreatic surgery.
Key exclusion criteria (4 listed)
- If not oliguric (urinary output <0,5 mls/kg/h) during their stay in the postoperative department
- Hemodynamic instability (the need for >0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).
- Patients that do not want to be a part of the study.
- <18 years old
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 |
|---|---|---|
| Ringer's AcetateAlso: Ringer AcetateWill receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours | Drug | Standard of care group |
Primary outcome
Urinary output
Time frame: 2 hours
Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..
8 secondary outcomes
Renal function
Time frame: 48 hours
Cumulative fluid balance
Time frame: 48 hours
Postoperative complications
Time frame: 90 days
Renal replacement therapy
Time frame: Up to 90 days
Mortality
Time frame: 90 days
Inotropy
Time frame: 1 week
Vasopressin (ADH)
Time frame: 1 day
S-osmolality
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Stopped after interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Miklos Lipcsey, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Acetate in people with Fluid Therapy and Postoperative Period, run by Uppsala University at 1 site in Sweden.
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 4 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: stopped early, as of the sponsor's last update on 10 Oct 2022. 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 Sweden. 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 was stopped early (reason given: Stopped after interim analysis). Results are not available in the source record.
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?
Urinary output (time frame: 2 hours). 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 10 Oct 2022.