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CTRI Number  CTRI/2024/02/062284 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of role of serum chloride levels in heart failure patients 
Scientific Title of Study   Hypochloremia as a predictor of In Hospital Outcome in Patients with Acute Decompensated Heart Failure 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mujahed Ahmed 
Designation  Junior Resident , Department of General Medicine 
Affiliation  Kasturba medical college, Manipal 
Address  Department of General Medicine, Second floor, OPD block Kasturba medical college, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9900269546  
Fax    
Email  mujahed.ahmed44@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukhyaprana Prabhu 
Designation  Professor 
Affiliation  Kasturba medical college, Manipal 
Address  Department of General Medicine, Second floor, OPD block Kasturba medical college, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449592986  
Fax    
Email  mm.prabhu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Noubade 
Designation  Senior Resident  
Affiliation  Kasturba medical college, Manipal 
Address  Department of General Medicine, Second floor, OPD block Kasturba medical college, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8310090260  
Fax    
Email  rakesh.noubade@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college, manipal 
 
Primary Sponsor  
Name  Dr Mujahed Ahmed 
Address  Department of General Medicine, Second floor, OPD block Kasturba medical college, Manipal Udupi Karnataka India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mujahed Ahmed  Kasturba medical college, Manipal  Department of General Medicine, Second floor, OPD block Udupi, 576104 Karnataka India
Udupi
KARNATAKA 		 9900269546

mujahed.ahmed44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I50||Heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted with diagnosis of acute decompensated heart failure will be included in the study 
 
ExclusionCriteria 
Details  1)individuals less than 18 years
2)Pregnant women
3)Patients with acute Myocardial infarction
4)Patients with myocarditis
5)CKD patients
6)Patients in sepsis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between admission chloride levels and duration of hospital stay in patients with acute decompensated heart failure  At the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Heart failure (HF) is a major health problem in India with a post admission mortality of 20%–30%.[2
HF is one of the leading causes of hospitalization for patients aged 65 and above.
Most of the literature in HF till recently has primarily focused on hyponatremia as the major predictor of short and long-term morbidity and mortality.
 Historically, sodium alone has been considered as the major contributor to volume homeostasis, and limited research attention has been given to chloride, a major extracellular anion that is abundantly present in intravascular and interstitial compartments and that counterbalances the positive charges of sodium.  
 Several studies have found that the single best predictor of mortality was an elevated blood urea nitrogen (>43 mg/dl), followed by low systolic blood pressure (<115mm Hg) and high serum creatinine (>2.75mg/dl), additional factors being presence of congestion, reduced left ventricular ejection fraction (LVEF), ischemic etiology, anemia, elevated natriuretic peptide levels.
 Recent epidemiological studies have implicated chloride, rather than sodium, as the driver and predictor of poor survival previously attributed to hyponatremia in heart failure.

DESCRIPTION
Patients with diagnosis of acute decompensated heart failure admitted in Kasturba Hospital, In Department of Medicine and Department Of Cardiology in Wards, HDUs,ICUs will be divided into tertiles based on admission chloride levels.
 The following details of all patients will be included in the study.
 Age, sex, demographic data and comorbidities.
 History with particular emphasis on treatment history and cardiac symptomatology before admission and through the course of hospital stay.
 Physical examination with focus on weight, jugular venous pressure (JVP), pedal edema, cardiac auscultation.
 Investigations to be done:  echocardiography, Serum electrolytes, Serum uric acid, NT pro BNP, Renal Function Test (RFT), Liver Function Test (LFT), Complete Blood Count (CBC).

All the quantitative parameters such as age of patient and length of stay , serum chloride level,serum potassium, serum urea, serum creatinine, haemoglobin levels, ejection fraction( EF%) and serum sodium levels will be expressed as mean and standard deviation or median with interquartile range in case of  non-normality of data. 

 

Categorical variables, such as gender, presence of diabetes mellitus, hypertension, smoking, etc. will be presented as percentages. The differences in the mean values of various parameters such as mean length of stay, blood urea nitrogen, serum potassium, sodium, uric acid, NT pro BNP, etc. amongst different serum chloride levels will be tested for statistical significance by analysis of variance or by non-parametric test of significance in case of non-normality of the data. 

 

The relationship between the length of stay and serum chloride levels will be assessed by estimating correlation coefficient. Multiple correlational coefficient will also be calculated to evaluate the relationship of serum chloride levels with length of stay considering the other confounding factors such as blood urea nitrogen, serum potassium, sodium, uric acid, NT pro BNP. 

 

Differences in mean or median values between the two groups such as serum chloride <96meq/L, >101 meq/L will be tested for statistical significance by Student –t test or Mann-Whitney test in case of non-normality of the data. Similarly, association of various qualitative variables such as presence of various comorbidities with different groups of serum chloride levels will be tested for statistical significance by Chi-Square test of significance.


 
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