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CTRI Number  CTRI/2018/06/014483 [Registered on: 08/06/2018] Trial Registered Retrospectively
Last Modified On: 07/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparison of Balanced Salt Solution Vs. Normal Saline in Major Abdominal Surgery. 
Scientific Title of Study   A Comparison of Balanced Salt Solution vs. Normal Saline in Major Abdominal Surgery: A Quantitative Acid Base Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa Joshiya 
Designation  M.D. Anesthesia 
Affiliation  PGIMER 
Address  C/o Dr. Kamal Kajal Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
C/o Dr. Kamal Kajal Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9914345544  
Fax    
Email  sjoshiya15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kamal Kajal 
Designation  Assistant professor 
Affiliation  PGIMER 
Address  Dr. Kamal Kajal Assistant Professor Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
Dr. Kamal Kajal Assistant Professor Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9560412726  
Fax    
Email  kamal.kajal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shilpa Joshiya 
Designation  M.D. Anesthesia 
Affiliation  PGIMER 
Address  C/o Dr. Kamal Kajal Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
C/o Dr. Kamal Kajal Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9914345544  
Fax    
Email  sjoshiya15@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, CHANDIGARH 
 
Primary Sponsor  
Name  Shilpa Joshiya 
Address  C/o Dr. Kamal Kajal Dept of anaesthesia and Intensive care 4th floor Nehru Hospital PGIMER Chandigarh 160012 
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 
Shilpa Joshiya  PGIMER  Dept. of Anesthesia and Intensive Care 4th floor, Nehru Hospital PGIMER
Chandigarh
CHANDIGARH 
9914345544

sjoshiya15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult ASA physical status I- III patients presenting for elective open abdominal surgery under General Anesthesia at PGIMER.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline  Patient received a bolus of 150 ml of normal saline at induction and 2ml/kg/hr + urine output + blood loss every hour. At hypotension fluid challenges were triggered by SPV or PPV as per the decision algorithm constructed. 
Intervention  Plasmalyte A  Patient received a bolus of 150 ml of study fluid at induction and 2ml/kg/hr + urine output + blood loss every hour. At hypotension fluid challenges were triggered by SPV or PPV as per the decision algorithm constructed. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult ASA physical status I-III patients presenting for elective open abdominal surgery under GA at PGIMER, Chandigarh. 
 
ExclusionCriteria 
Details  Patients with pre-existing renal dysfunction (Sr. creatinine > 1.5mg/dl), those with abnormal sodium, potassium, chloride levels on pre-operative biochemistry screen, resting elevations of PaCO2, known clinical lung disease, H/O congestive heart failure or pulmonary hypertension, pre-operative use of diuretic or steroid replacement therapy, Hb<7gm/dl and those refusing consent were excluded from study participation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in chloride concentration of less than 3 mEq/L between the plasmalyte and normal saline groups at the end of surgery with restrictive fluid regimen.  Difference in chloride concentration of less then 3 mEq/L  
 
Secondary Outcome  
Outcome  TimePoints 
Acidosis at first post operative day .  pH less than 7.35 
decreased urine output with restrictive regimen leading to risk of renal injury  urine output less than 0.5ml/kg/hr .
risk of renal injury by RIFLE criteria. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) 01/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    The acidosis attributed to Normal Saline has a clear dose-dependent effect with larger volumes associated with this phenomenon. However, the exact quantitative impact of this solution when used in a restrictive paradigm is not adequately assessed in the current literature. Thus, this study attempted to assess the effects of Plasmalyte vs. Normal saline when used in restrictive quantities as determined by a pre-defined hemodynamic algorithm which used dynamic indices like SPV and PPV. Such an assessment was made on the freely available physicochemical acid-base calculator designed by John Kellum and provided as an editable excel sheet. It was hypothesized that the quantitative differences between the two infusion fluids under study would likely not be significant to alter clinical outcomes. 

  The aim was to determine the equivalence or otherwise of Normal Saline in comparison to Plasmalyte for intra-operative fluid replacement in elective, adult open abdominal surgery on serum chloride level using a restrictive fluid therapy algorithm. 

 Previous studies had reported a difference of approximately 6 mEq/l in the chloride levels when saline was used in comparison to Plasmalyte at the volumes infused in the study. We hypothesized that the difference would be much smaller (<3 mEq/L) when smaller volumes ( 2ml/kg/hr + urine output + blood loss every hour ) of fluid were infused using a dynamic index to titrate fluid therapy and that both fluids would be demonstrated to be equivalent.

  SUMMARY and RESULTS:1) Restrictive fluid regimen shows equivalence in the choice of crystalloid fluid ( Plasmalyte versus Normal saline) used for intraoperative fluid therapy. 
2) Infusing fluids according to the algorithm lead to a decrease in pH but not significant acidosis (pH< 7.35) in both the groups even at postoperative day one.
3)The constituents of crystalloids have an impact on the acid-base balance as seen with changes in independent parameters of Stewart. These changes may become significant if fluids are given in larger volume for a longer duration. 
4) Normal saline has an obvious impact on urine output even when given in restricted amounts but these did not amount to renal injury. 
5) In surgeries of prolonged duration with a restrictive regimen, a close watch on lactate to prevent tissue hypoperfusion is necessary which shows a trend of increase with duration of surgery in our study. 
6) Dynamic indices like PPV are effective in guiding fluid therapy intraoperatively.


 
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