Acute PancreatitisNCT00853515
Goal-directed Fluid Resuscitation in Acute Pancreatitis
A study testing Goal-directed fluid resuscitation in people with Acute Pancreatitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Goal-directed fluid resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2010
- 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
- acute pancreatitis diagnosed by at least 2 criteria
- adult patients at least 18 years of age
Who cannot join
- history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
- concurrent metabolic or physiologic derangement requiring specific fluid management
- pregnancy
- patients transferred from acute care hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis
Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.
Read the detailed description
Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.
Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.
- Conditions
- Acute Pancreatitis
- Being tested
- Goal-directed fluid resuscitation
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed fluid resuscitationOther
Targeted, weight-based fluid resuscitation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Goal-directed fluid resuscitation with lactated Ringer's solution Receives: Other: Goal-directed fluid resuscitation |
| 2 | Experimental | Goal-directed fluid resuscitation with normal saline Receives: Other: Goal-directed fluid resuscitation |
| 3 | No intervention | Standard fluid resuscitation with lactated Ringer's solution |
| 4 | No intervention | Standard fluid resuscitation with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
Measured: first 24 hours of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionJun 2010
Why it stopped: interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Bechien Wu, MD, MPH, Brigham and Women's Hospital
- Investigators
- Bechien U. Wu, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853515
- Sponsor's protocol ID
- 2008-P-001757
- Status last verified
- Dec 2016
- First submitted
- 27 Feb 2009
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00853515
- Acronym / sponsor ID
- 2008-P-001757
- Conditions
- Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Mar 2009 (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.
Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.
Detailed description
Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.
Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Goal-directed fluid resuscitationGoal-directed fluid resuscitation with lactated Ringer's solution |
| 2 | Experimental | Other: Goal-directed fluid resuscitationGoal-directed fluid resuscitation with normal saline |
| 3 | No intervention | –Standard fluid resuscitation with lactated Ringer's solution |
| 4 | No intervention | –Standard fluid resuscitation with normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute pancreatitis diagnosed by at least 2 criteria
- adult patients at least 18 years of age
Key exclusion criteria (4 listed)
- history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
- concurrent metabolic or physiologic derangement requiring specific fluid management
- pregnancy
- patients transferred from acute care hospital
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 resuscitationTargeted, weight-based fluid resuscitation | Other | 1, 2 |
Primary outcome
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
Time frame: first 24 hours of hospitalization
Results and safety
The study was stopped early (reason given: interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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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.
Bechien U. Wu, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed fluid resuscitation in people with Acute Pancreatitis, run by Brigham and Women's Hospital 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 2 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 9 Dec 2016. 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.
Are results available for this study?
The study was stopped early (reason given: interim analysis incidence primary endpoint lower than anticipated. Sigicant finding based on secondary endpoint.). 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?
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours (time frame: first 24 hours of hospitalization). 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 9 Dec 2016.