UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035295
Receipt No. 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 (Ver. 6)

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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
Email 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
Email binodkarki@yahoo.com

Sponsor
Institute Bir Hospital National Academy of Medical sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040213