FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/025964 [Registered on: 18/06/2020] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   to study the levels of sodium and other salts in the blood and urine of severely ill patients  
Scientific Title of Study   Profile of serum and urinary electrolytes in critically ill patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varun Kumar Bandi 
Designation  Assistant Professor 
Affiliation  Dr. Pinnamaneni Siddhartha Institue of Medical Sciences and RF 
Address  Department of Nephrology, Super-speciality Block, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF

Krishna
ANDHRA PRADESH
521286
India 
Phone  7708396309  
Fax    
Email  varun.vims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Varun Kumar Bandi 
Designation  Assistant Professor 
Affiliation  Dr. Pinnamaneni Siddhartha Institue of Medical Sciences and RF 
Address  Department of Nephrology, Super-speciality Block, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF


ANDHRA PRADESH
521286
India 
Phone  7708396309  
Fax    
Email  varun.vims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varun Kumar Bandi 
Designation  Assistant Professor 
Affiliation  Dr. Pinnamaneni Siddhartha Institue of Medical Sciences and RF 
Address  Department of Nephrology, Super-speciality Block, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF


ANDHRA PRADESH
521286
India 
Phone  7708396309  
Fax    
Email  varun.vims@gmail.com  
 
Source of Monetary or Material Support  
Monetary and Material support: Monetary support: Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF, Chinna avutapalli, Gannavaram mandal, Krishna district, Andhra Pradesh - 521286 
Monetary support: Varun Kumar B, Department of Nephrology, Super-speciality Block, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF, Chinna avutapalli, Gannavaram mandal, Krishna district, Andhra Pradesh - 521286 
 
Primary Sponsor  
Name  Varun Kumar B 
Address  Department of Nephrology, Super-speciality Block, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and RF, Chinna Avutapalli, Andhra Pradesh 
Type of Sponsor  Other [Individual] 
 
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 
Varun Kumar B  Dr Pinnamaneni Siddhartha Institute of Medical Sciences and RF  Medical ICU, Third floor, Speciality block
Krishna
ANDHRA PRADESH 
7708396309

varun.vims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and RF IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A418||Other specified sepsis, (2) ICD-10 Condition: A419||Sepsis, unspecified organism, (3) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (4) ICD-10 Condition: A488||Other specified bacterial diseases, (5) ICD-10 Condition: A410||Sepsis due to Staphylococcus aureus, (6) ICD-10 Condition: A411||Sepsis due to other specified staphylococcus, (7) ICD-10 Condition: A400||Sepsis due to streptococcus, groupA, (8) ICD-10 Condition: A401||Sepsis due to streptococcus, groupB, (9) ICD-10 Condition: A403||Sepsis due to Streptococcus pneumoniae, (10) ICD-10 Condition: A408||Other streptococcal sepsis, (11) ICD-10 Condition: B952||Enterococcus as the cause of diseases classified elsewhere, (12) ICD-10 Condition: B961||Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere, (13) ICD-10 Condition: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere, (14) ICD-10 Condition: B964||Proteus (mirabilis) (morganii) asthe cause of diseases classified elsewhere, (15) ICD-10 Condition: B965||Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere, (16) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (17) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, (18) ICD-10 Condition: B998||Other infectious disease, (19) ICD-10 Condition: B999||Unspecified infectious disease, (20) ICD-10 Condition: A91||Dengue hemorrhagic fever, (21) ICD-10 Condition: A99||Unspecified viral hemorrhagic fever, (22) ICD-10 Condition: J159||Unspecified bacterial pneumonia, (23) ICD-10 Condition: I509||Heart failure, unspecified, (24) ICD-10 Condition: J189||Pneumonia, unspecified organism, (25) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (26) ICD-10 Condition: K709||Alcoholic liver disease, unspecified, (27) ICD-10 Condition: K720||Acute and subacute hepatic failure, (28) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, (29) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified, (30) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (31) ICD-10 Condition: N179||Acute kidney failure, unspecified, (32) ICD-10 Condition: N19||Unspecified kidney failure, (33) ICD-10 Condition: R060||Dyspnea, (34) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 18 years and above.
2. Critically ill patients admitted to the Medical ICU
 
 
ExclusionCriteria 
Details  1. Age less than 18 years
2. Patients not willing to participate
3. Pregnant women
4. Patients admitted to Surgical ICU
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality  At hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of ICU stay  At hospital discharge 
Duration of hospital stay  At hospital discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/07/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

Intensive care unit (ICU) services require expensive technology, and account for as much as 10 percent of all health care costs. The outcome of critically ill patients is therefore of importance not only to the patients and their families, but also to the society. After admission to the ICU, the outcome is dependent upon both the diagnosis and management of the primary illness and, in many cases, the presence or absence of multi-organ involvement.1

On the other hand, electrolytes such as potassium, sodium, chloride, magnesium, calcium and phosphate play important roles in cellular metabolism and energy transformation, and in the regulation of cell membrane potentials, especially those of muscle and nerve cells, which demonstrate their important role in the outcome of critically ill patients. Depletion of these electrolytes can induce a wide range of clinical disorders, including neuromuscular dysfunction and severe arrhythmias. The risk for these disorders increases significantly when more than one electrolyte is deficient.2

It is well known that hypokalemia can induce cardiac arrhythmias (especially in patients with ischemic heart disease and left ventricular hypertrophy), and that it is associated with other adverse effects such as muscle weakness, rhabdomyolysis, renal failure and hyperglycemia. Additionally, hyperkalemia may cause symptoms such as severe muscle weakness or paralysis and cardiac conduction abnormality which may lead to adverse outcomes in ill ICU patients.3-6

Moreover, hyponatremia is a common electrolyte abnormality in critically ill patients.6-9The risk of hyponatremia among hospitalized patients is influenced by the underlying disease state and clinical circumstances. Another sodium disturbance, hypernatremia, is basically a mirror image of hyponatremia6,10-12and can cause rupture of the cerebral veins, leading to focal intracerebral and subarachnoid hemorrhages and possible irreversible neurologic damage. The clinical manifestations of this disorder begin with lethargy, weakness, and irritability, and can progress to twitching, seizures, and coma

The importance of regulating potassium and sodium levels is well recognized in most intensive care units (ICUs) and the development of many electrolyte disturbances in the ICU can be prevented by attention to the usual intravenous fluids and nutrition. On the other hand, chloride levels have not been studied extensively. Chloride is the most abundant anion in the extracellular fluid and constitutes approximately one-third of the extracellular fluid tonicity.13Chloride plays a pivotal role in many body functions including acid-base balance, muscular activity, osmosis, and immunomodulation.14Despite its physiological importance, chloride has captured little attention by the scientific community until recently15when chloride-rich solutions were associated with hyperchloremic metabolic acidosis16,17and short-term mortality after non-cardiac surgery.18,19

The most common chloride-rich solution utilized in clinical practice is 0.9% saline20, particularly in critical illness and perioperatively. 0.9% saline is in reality a non-neutral solution21and has a supraphysiologic amount of chloride when compared to plasma (154 vs ~100 mEq/L, respectively).22,23The consequent hyperchloremic metabolic acidosis derived from the liberal use of chloride-rich solutions has been described as a common but poorly recognized disorder in critically ill patients24,25, with numerous detrimental consequences26,27, particularly in those with severe sepsis and septic shock.28

The purpose of our study was to determine whether there was an independent association of serum and urinary electrolyte levels at 2 different time points of ICU stay with hospital mortality in critically ill septic patients. The 2 evaluated time points were ICU admission (t0) and at 48-72 h of ICU stay (t72). 

 

Objectives

·     To evaluate the profile of serum and urinary electrolytes in critically ill patients.

·     To study the association of serum and urinary electrolytes with short-term mortality in critically ill patients

·     To evaluate any association between serum and urinary electrolytes and Acute Kidney Injury in critically ill patients.

 

Methodology:

All critically ill patients admitting in the Medical ICU of Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & RF will be screened for inclusion in the study.  Participants/Attendants if willing for the study, and who have reports of serum electrolytes performed within three hours of admission to the ICU will be enrolled.

The baseline characteristics such as Age, Gender, history of Diabetes Mellitus, Hypertension, Cardiac disease, kidney disease, smoking and alcohol history will be obtained. The patient’s diagnosis will be noted from the medical records. The subjects blood pressure (BP) will be recorded from the medical records. 

 

The reports of the following investigations done within 3 hours of ICU admission will be collected: Hemoglobin (Hb), Random blood sugar (RBS), serum creatinine, serum electrolytes (sodium, potassium, chloride), Calcium, Phosphorous, Total Bilirubin, serum Albumin and Arterial Blood Gas analysis. Patients with incomplete reports will be excluded from the study. The patients spot urinary electrolytes and urinary creatinine will be measured (t0). Serum and urinary electrolytes will be repeated again between 48-72 hours after admission (t72). Biochemical investigations will be done as per the standard hospital methodology. eGFR will be calculated using CKD-EPI equation. Lower levels of laboratory reference values will be used as the cutoff points for clinically significant electrolyte depletion, and the upper levels as cutoff points for significant increase in electrolyte concentration. 

The patients will be followed up and the development of AKI, cumulative fluid balance in ICU, in-ICU mortality, in-hospital mortality, duration of ICU stay and duration of hospital stay will be recorded. The patients will be contacted and followed up at three months to identify mortality upto three months.

References:

1.   Sedlacek M, Schoolwerth AC, Remillard BD. Electrolyte disturbances in the intensive care unit. Semin Dial 2006; 19 (6): 496- 501. 

2.    Ducceschi V, D’Andrea A, Liccardo B, Sarubbi B, Ferrara L, Romano GP, et al. Ventricular tachyarrhythmias following coronary surgery: predisposing factors. Int J Cardiol 2000; 73 (1): 43- 8. 

3.    Muensterer OJ. Hyperkalaemic paralysis. Age Ageing 2003; 32 (1): 114- 5. 

4.    Livingstone IR, Cumming WJ. Hyperkalaemic paralysis resembling Guillain-Barré syndrome. Lancet 1979; 2 (8149): 963- 4. 

5.    Bashour T, Hsu I, Gorfinkel HJ, Wickramesekaran R, Rios JC. Atrioventricular and intraventricular conduction in hyperkalemia. Am J Cardiol 1975; 35 (2): 199- 203. 

6.    Lee JW. Electrolyte Blood Press. 2010 Dec;8(2):72-81. Fluid and electrolyte disturbances in critically ill patients. 

7.    Friedman B, Cirulli J. Hyponatremia in critical care patients: Frequency, outcome, characteristics, and treatment with the vasopressin V(2)-receptor antagonist tolvaptan. J Crit Care 2012. 

8.    Amin A, Deitelzweig S, Christian R, Friend K, Lin J, Belk K, et al. Evaluation of incremental healthcare resource burden and readmission rates associated with hospitalized hyponatremic patients in the US. J Hosp Med 2012; 7 (8): 634- 9. 

9.    Mannesse CK, Vondeling AM, van Marum RJ, van Solinge WW, Egberts TC, Jansen PA. Prevalence of hyponatremia on geriatric wards compared to other settings over four decades: A systematic review. Ageing Res Rev 2012; 12 (1): 165- 173. 

10.Rose BD, Post TW. Clinical Physiology of Acid-Base and Electrolyte Disorders, 5th ed, McGraw-Hill, New York, 2001, pp. 716-720, 761-764. 

11.Strange K. Regulation of solute and water balance and cell volume in the central nervous system. J Am Soc Nephrol 1992; 3 (1): 12- 27. 

12.Adrogué HJ, Madias NE. Hypernatremia. N Engl J Med 2000; 342 (20): 1493- 9. 

13.Hall, JE.; Guyton, AC. Guyton and Hall textbook of medical physiology. 12. Philadelphia, Pa: Saunders/Elsevier; 2011. 

14.Berend K, van Hulsteijn LH, Gans RO. Chloride: the queen of electrolytes? Eur J Intern Med. 2012; 23(3):203–211.

15.Yunos NM, Bellomo R, Story D, et al. Bench-to-bedside review: Chloride in critical illness. Critical care. 2010; 14(4):226.

16.Scheingraber S, Rehm M, Sehmisch C, et al. Rapid saline infusion produces hyperchloremic acidosis in patients undergoing gynecologic surgery. Anesthesiology. 1999; 90(5):1265–1270.

17.Mann C, Held U, Herzog S, et al. Impact of normal saline infusion on postoperative metabolic acidosis. Paediatr Anaesth. 2009; 19(11):1070–1077.

18.Silva JM Junior, Neves EF, Santana TC, et al. The importance of intraoperative hyperchloremia. Rev Bras Anestesiol. 2009; 59(3):304–313.

19.McCluskey SA, Karkouti K, Wijeysundera D, et al. Hyperchloremia after noncardiac surgery is independently associated with increased morbidity and mortality: a propensity-matched cohort study. Anesth Analg. 2013; 117(2):412–421. 

20.Powell-Tuck, J.; Gosling, P.; Lobo, DN., et al. British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients (GIFTASUP). The British Association for Parenteral and Enteral Nutrition (BAPEN); 2008. (updated 2011). Available at http://www.bapen.org.uk/pdfs/ bapen_pubs/giftasup.pdf 

21.Story DA, Thistlethwaite P, Bellomo R. The effect of PVC packaging on the acidity of 0. 9% saline. Anaesth Intensive Care. 2000; 28(3):287–292.

22.Guidet B, Soni N, Della Rocca G, et al. A balanced view of balanced solutions. Critical care. 2010; 14(5):325. 

23.Veech RL. The toxic impact of parenteral solutions on the metabolism of cells: a hypothesis for physiological parenteral therapy. Am J Clin Nutr. 1986; 44(4):519–551.

24.Moviat M, van den Boogaard M, Intven F, et al. Stewart analysis of apparently normal acid-base state in the critically ill. J Crit Care. 2013; 28(6):1048–1054.

25.O’Dell E, Tibby SM, Durward A, et al. Hyperchloremia is the dominant cause of metabolic acidosis in the postresuscitation phase of pediatric meningococcal sepsis. Crit Care Med. 2007; 35(10):2390–2394.

26.Lobo DN, Awad S. Should chloride-rich crystalloids remain the mainstay of fluid resuscitation to prevent ’pre-renal’ acute kidney injury?: con. Kidney Int. 2014; 86(6):1096–1105.

27.Krajewski ML, Raghunathan K, Paluszkiewicz SM, et al. Meta-analysis of high- versus low- chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015; 102(1):24– 36.

28.Noritomi DT, Soriano FG, Kellum JA, et al. Metabolic acidosis in patients with severe sepsis and septic shock: a longitudinal quantitative study. Crit Care Med. 2009; 37(10):2733–2739. 

29.Mousavi SAJ, Shahabi S, Mostafapour E, Purfakharan M, Fereshtehnejad SM, Amini J et al. Comparision of the serum electrolyte levels among patients died and survived in the intensive care unit. Tanaffos 2012; 11(4): 36-42.

30.Panda I, Save S. Study of association of mortality with electrolyte abnormalities in children admitted in pediatric intensive care unit. Int J Contemp Pediatr 2018; 5(3): 1097-1103.

31.Neyra JA, Canepa-Escaro F, Li X, Manllo J, Adams-Huet B, Yee J et al. Association of hyperchloremia with hospital mortality in critically ill septic patients. Crit Care Med 2015; 43(9): 1938-1944.

 
Close