Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069284
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-15
Brief Title:
Prognostic Significance of Acute Change in Liver and Splenic Stiffness in Patients of Acute on Chronic Liver Failure
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Prognostic Significance of Acute Change in Liver and Splenic Stiffness in Patients of Acute on Chronic Liver Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute-on-chronic liver failure ACLF is a syndrome associated with a high short- term mortality Early identification of patients at high risk is important to determine emergency for transplantation and prioritize the need for intensive care unit Unbalanced systemic inflammatory response is closely associated with mortality in ACLF patients This systemic inflammatory response in ACLF increases liver and splenic stiffness stiffnes which can be detected by transient elastography
Very few studies have been done in past evaluating liver and splenic stiffness as prognostic tool in patients of ACLF These studies have taken only single value of liver and splenic stiffness as prognostic tool No follow up study have yet been done assessing acute change in liver and splenic stiffness in ACLF In this study we hypothesize that acute change in liver and splenic stiffness at 7th 14 th day predicts outcome in ACLF patients With this study we aim to evaluate whether acute changes in liver and splenic stiffness at 7th 14th day predicts outcome at 3 months in patients of ACLF
Very few studies have been done in past evaluating liver and splenic stiffness as prognostic tool in patients of ACLF These studies have taken only single value of liver and splenic stiffness as prognostic tool No follow up study have yet been done assessing acute change in liver and splenic stiffness in ACLF In this study we hypothesize that acute change in liver and splenic stiffness at 7th 14 th day predicts outcome in ACLF patients With this study we aim to evaluate whether acute changes in liver and splenic stiffness at 7th 14th day predicts outcome at 3 months in patients of ACLF
Detailed Description:
Study Design 1 year prospective cohort study Hypothesis We hypothesize that acute change in liver and splenic stiffness at 7th 14 th day predicts outcome in ACLF patients
Aim and Objective - Primary objective To study the change in liver and splenic stiffness values at day 7 from baseline at day 1 between those with or without transplant free survival at Day 90
Secondary objectives
1 To study the change in liver and splenic stiffness values at day 14 from baseline at day 1 between those with or without transplant free survival at Day 90
1 To evaluate association of baseline and change in liver and splenic stiffness with different etiologies of ACLF
2 To evaluate association of baseline liver and splenic stiffness with grade of esophageal varices in ACLF patients
3 To evaluate association of baseline and change in liver and splenic stiffness with pattern of organ failures
4 To evaluate association of changes in level of biochemical inflammatory markers with change in liver and splenic stiffness
5 To evaluate association of baseline liver and splenic stiffness with severity of ACLF by AARC-ACLF scoreCLIF-C-ACLF score MELD-Na and CTP at presentation
6 To evaluate change in liver and splenic stiffness with change in AARC-ACLF score and CLIF-C-ACLF score
Methodology
Study population All the consecutive patients of ACLF admitted in Hepatology wards will be evaluated for inclusion criteria
Study design Prospective cohort study
Study period 1 year after IEC approval
Sample size Consecutive patients of ACLF from approval of study to 12 months 200 patients will be enrolled in our study
Intervention None
Monitoring and assessment All enrolled patients will undergo detailed evaluation by thorough history clinical examination and relevant laboratory investigations Patients will be graded as per AARC score grade I 5-7 II 8-10 III 11-15 CBC NLR KFT LFT PTINR at baseline and alternate day till discharge or deathLiver transplantation TNF alpha IL-6 CRP ferritin lactate at day 1 day 7 and day 14 AARC-ACLF score and CLIF-C-ACLF score at day 1 day 7 and day 14USG abdomen and hepatic vein porto-splenic doppler study will be performed in all cases and triple phase CT of abdomen when there will be suspicion of HCC Fibroscan of liver and spleen at day 1 day 7 and day 14UGI endoscopy will be performed within 7 days
Initial Liver and Splenic stiffness and follow-up tests Liver and splenic stiffness TNF-alpha IL-6 will be done free of cost
STATISTICAL ANALYSIS
Baseline data will be expressed as a proportion the continuous data will be presented as mean-SD OR mean SD or median IQR
To compare between the groups either Students t-test Mann Whitney test will be applied as appropriate
The categorical data will be analysed using χ2test or Fishers exact test The change between pre- and post-values will be analysed using paired t-test or McNemar test
Significance defined as 2-tailed p-value of less than 005 Survival curves will be represented using Kaplan-Meier method
ITT Per protocol analysis will be carried out for final result assessment The data will be entered in Microsoft excel format and to be analysed using SPSS version 22 IBM corp Ltd Armonk NY USA
Adverse effects NA
Aim and Objective - Primary objective To study the change in liver and splenic stiffness values at day 7 from baseline at day 1 between those with or without transplant free survival at Day 90
Secondary objectives
1 To study the change in liver and splenic stiffness values at day 14 from baseline at day 1 between those with or without transplant free survival at Day 90
1 To evaluate association of baseline and change in liver and splenic stiffness with different etiologies of ACLF
2 To evaluate association of baseline liver and splenic stiffness with grade of esophageal varices in ACLF patients
3 To evaluate association of baseline and change in liver and splenic stiffness with pattern of organ failures
4 To evaluate association of changes in level of biochemical inflammatory markers with change in liver and splenic stiffness
5 To evaluate association of baseline liver and splenic stiffness with severity of ACLF by AARC-ACLF scoreCLIF-C-ACLF score MELD-Na and CTP at presentation
6 To evaluate change in liver and splenic stiffness with change in AARC-ACLF score and CLIF-C-ACLF score
Methodology
Study population All the consecutive patients of ACLF admitted in Hepatology wards will be evaluated for inclusion criteria
Study design Prospective cohort study
Study period 1 year after IEC approval
Sample size Consecutive patients of ACLF from approval of study to 12 months 200 patients will be enrolled in our study
Intervention None
Monitoring and assessment All enrolled patients will undergo detailed evaluation by thorough history clinical examination and relevant laboratory investigations Patients will be graded as per AARC score grade I 5-7 II 8-10 III 11-15 CBC NLR KFT LFT PTINR at baseline and alternate day till discharge or deathLiver transplantation TNF alpha IL-6 CRP ferritin lactate at day 1 day 7 and day 14 AARC-ACLF score and CLIF-C-ACLF score at day 1 day 7 and day 14USG abdomen and hepatic vein porto-splenic doppler study will be performed in all cases and triple phase CT of abdomen when there will be suspicion of HCC Fibroscan of liver and spleen at day 1 day 7 and day 14UGI endoscopy will be performed within 7 days
Initial Liver and Splenic stiffness and follow-up tests Liver and splenic stiffness TNF-alpha IL-6 will be done free of cost
STATISTICAL ANALYSIS
Baseline data will be expressed as a proportion the continuous data will be presented as mean-SD OR mean SD or median IQR
To compare between the groups either Students t-test Mann Whitney test will be applied as appropriate
The categorical data will be analysed using χ2test or Fishers exact test The change between pre- and post-values will be analysed using paired t-test or McNemar test
Significance defined as 2-tailed p-value of less than 005 Survival curves will be represented using Kaplan-Meier method
ITT Per protocol analysis will be carried out for final result assessment The data will be entered in Microsoft excel format and to be analysed using SPSS version 22 IBM corp Ltd Armonk NY USA
Adverse effects NA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None