Acute PancreatitisPhase 4NCT04688645
Balanced Crystalloid Solutions for Acute Pancreatitis
A Phase 4 study testing Balanced crystalloid solution and Normal saline in people with Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
Trial summary
Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. 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?
- Balanced crystalloid solution and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteCroatia
- Study dates
- 1 May 2020to 1 Feb 2023
- Phase
- Phase 4
- 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 diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis
Who cannot join
- chronic pancreatitis
- liver cirrhosis (Child-Pugh B and C)
- chronic hearth failure (NYHA>II)
- acute coronary syndrome
- cardiovascular intervention within 60 days before randomization
- chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
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- chronic kidney disease (eGFR <30 ml/min/1.73 m2)
- concomitant biliary infection (cholecystitis, cholangitis)
- severe autoimmune disease
- chronic active infection (TBC, AIDS)
- metastatic malignant disease
- primary pancreatic neoplasm
- patients transferred from other hospitals
- pregnancy and ongoing breastfeeding
- not willing to participate
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Rijeka
Rijeka, 51000
Goran Poropat, MD, PhD, 0038551658379, gporopat8@gmail.com
About this study
Official title: Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.
- Conditions
- Acute Pancreatitis
- Being tested
- Balanced crystalloid solution, Normal saline
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced crystalloid solutionDrug
Also called Plasmalyte; balanced crystalloids
Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
Normal salineDrug
Also called Saline; 0.9% sodium chloride solution
0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Balanced crystalloid solution | Experimental | Balanced crystalloid solution - Plasmalyte. Receives: Drug: Balanced crystalloid solution |
| Normal saline | Active comparator | 0.9% sodium chloride solution. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.
Measured: 30 days
Secondary outcomes (7)
Mortality
Number of death cases
Measured: 30 days
Number of participants with organ failure (transitory and persistent)
Organ failure defined according to the modified Marshall criteria
Measured: 30 days
Number of participants with local complications
Local complications including:
- acute peripancreatic fluid collection
- acute necrotic collection
- pseudocyst
- walled-off necrosis
Measured: 30 days
Number od participants with systemic complications
Worsening of existing concomitant diseases
Measured: 30 days
Number of participants with infected pancreatic necrosis
Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.
Measured: 30 days
Number of participants needing endoscopic / percutaneous / surgical interventions
In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention
Measured: 30 days
Length of hospital stay
Number of days in hospital, from admission to discharge or death.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 May 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Goran Poropat, University Hospital Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688645
- Sponsor's protocol ID
- uniri-biomed-18-154
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04688645
- Acronym / sponsor ID
- uniri-biomed-18-154
- Conditions
- Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 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.
Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced crystalloid solution | Experimental | Drug: Balanced crystalloid solutionBalanced crystalloid solution - Plasmalyte. |
| Normal saline | Active comparator | Drug: Normal saline0.9% sodium chloride solution. |
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 diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis
Key exclusion criteria (15 listed)
- chronic pancreatitis
- liver cirrhosis (Child-Pugh B and C)
- chronic hearth failure (NYHA>II)
- acute coronary syndrome
- cardiovascular intervention within 60 days before randomization
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 |
|---|---|---|
| Balanced crystalloid solutionAlso: Plasmalyte; balanced crystalloidsBalanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated. | Drug | Balanced crystalloid solution |
| Normal salineAlso: Saline; 0.9% sodium chloride solution0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated. | Drug | Normal saline |
Primary outcome
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Time frame: 30 days
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.
7 secondary outcomes
Mortality
Time frame: 30 days
Number of participants with organ failure (transitory and persistent)
Time frame: 30 days
Number of participants with local complications
Time frame: 30 days
Number od participants with systemic complications
Time frame: 30 days
Number of participants with infected pancreatic necrosis
Time frame: 30 days
Number of participants needing endoscopic / percutaneous / surgical interventions
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balanced crystalloid solution and Normal saline in people with Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
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 15 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: status not confirmed, as of the sponsor's last update on 30 Dec 2020. 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 Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goran Poropat, MD, PhD (0038551658191, gporopat8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS) (time frame: 30 days). 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 30 Dec 2020.