UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035295 |
|---|---|
| Receipt number | R000040213 |
| Scientific Title | Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis |
| Date of disclosure of the study information | 2018/12/30 |
| Last modified on | 2019/06/18 11:08:39 |
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Basic information
Public title
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
Acronym
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
Scientific Title
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
Scientific Title:Acronym
Fluids in Acute pancreatitis
Region
| Asia(except Japan) |
Condition
Condition
Acute Pancreatitis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effect on outcome of acute pancreatitis using Ringers lactate vs Normal saline
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the effect of initial resuscitation with Ringers Lactate versus Normal Saline on the outcome of acute pancreatitis
Key secondary outcomes
1. To analyze the difference in CRP in two groups as marker of systemic inflammation.
2. To analyze the difference in SIRS in two groups as marker of systemic inflammation.
3. To analyze the incidence of severity of diseases in both the groups as per the revised Atlanta classification.
4. To analyze the difference in complications of acute pancreatitis in both the groups.
5. To analyze the difference in length of hospital stay in both the groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All the patients who presented to the ER of Bir Hospital and diagnosed as acute pancreatitis using the Atlanta classification will be subjected to fluid resuscitation using Ringer lactate 10 ml/kg of the study fluid in 60 minutes immediately after randomization, and then 1.5 ml/kg/hour of the study fluid for three days. All patients will receive additional 1 liter of 5% dextrose per 24 hours. The amount of daily fluid administered were as per the standard guideline which is 250-400 ml per hour.
Interventions/Control_2
All the patients who presented to the ER of Bir Hospital and diagnosed as acute pancreatitis using the Atlanta classification will be subjected to fluid resuscitation using NS 10 ml/kg of the study fluid in 60 minutes immediately after randomization, and then 1.5 ml/kg/hour of the study fluid for three days. All patients will receive additional 1 liter of 5% dextrose per 24 hours. The amount of daily fluid administered were as per the standard guideline which is 250-400 ml per hour.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients diagnosed with acute pancreatitis presenting in emergency (ER) of Bir hospital
Key exclusion criteria
1. Patients below 18 yrs
2. Patients with co-morbid illness like chronic heart failure, chronic kidney disease.
3. Patients presenting to hospital for more than 48 hrs of symptoms or any transferred case from other hospital who are already resuscitated.
4. Patients with chronic obstructive pulmonary disease with requirement for home oxygen
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Binod |
| Middle name | |
| Last name | Karki |
Organization
Bir Hospital
National Academy of Medical Sciences
Division name
Gastroenterology
Zip code
44600
Address
Mahabaudhha, Kathmandu, Nepal.
TEL
009779851152447
binodkarki@yahoo.com
Public contact
Name of contact person
| 1st name | Binod |
| Middle name | |
| Last name | Karki |
Organization
Bir Hospital National Academy of Medical sciences
Division name
Gastroenterology
Zip code
44600
Address
Mahabaudhha, Kathmandu, Nepal.
TEL
009779851152447
Homepage URL
http://www.nams.org.np
binodkarki@yahoo.com
Sponsor or person
Institute
Bir Hospital National Academy of Medical sciences
Institute
Department
Personal name
Funding Source
Organization
Bir Hospital National Academy of Medical sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Nepalese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Academy of Medical Sciences
Address
Bir Hospital, Mahabaudhha, Kathmandu
Tel
+977-1-4230710
admin@nams.org.np
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
51
Results
26 participants in Ringer Lactate group and 25 in Normal saline group. Baseline characteristic and lab parameters were comparable in both the groups. SIRS and CRP were significantly less in RL group compared to NS group during treatment.
Results date posted
| 2019 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040213
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