| 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
|
|
|
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
|
|
|
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
|
|
|
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. |
|
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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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