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CTRI Number  CTRI/2023/07/055007 [Registered on: 10/07/2023] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [INTRAVENOUS FLUID MANAGEMENT]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Intraoperative fluid requirement with Conventional and goal-directed fluid management in neonates undergong laparotomy 
Scientific Title of Study   Intraoperative Liberal versus Goal-directed Fluid Therapy in Neonates undergoing Laparotomy- A Prospective Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anagha N Pervady 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anesthesia, Level 4, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9035156395  
Fax    
Email  anaghanp123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preethy J Mathew 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anesthesia, Level 4, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9417800203  
Fax    
Email  tjpreethy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preethy J Mathew 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anesthesia, Level 4, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  09417800203  
Fax    
Email  tjpreethy@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia, PGIMER, Chandigarh 
 
Primary Sponsor  
Name  Department of Anesthesia and Intensive Care 
Address  Level 4, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Anagha N Pervady  Postgraduate Institute of Medical Education and Research  Department of Anesthesia, Level 4, Nehru Hospital, Chandigarh
Chandigarh
CHANDIGARH 		 9035156395

anaghanp123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  PVI Monitor  Intraoperative Fluid Management throughout the duration of Surgery 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1. Term and Late preterm neonates, (GA> 35 weeks) up to 28 days of life.
2. Emergency procedures.
3. Anticipated duration of surgery > 60minutes
 
 
ExclusionCriteria 
Details  1. Children with associated medical conditions like Cardiac anomaly, Pulmonary anomaly/severe respiratory disease, Hepatic disease
2. Weight <2 kgs
3. Abdominal surgery where visceral exposure is not anticipated.
• Anticipated massive blood transfusion.
• Hb < 10 gm/dl
• Evidence of hypovolemia before induction of anaesthesia.
• Preoperative inotropes
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the total amount of fluid infused intraoperatively in ml/ kg in both the groups  END OF SURGERY 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative lactate & base excess levels  Baseline & at the end of surgery before shifting the patient out of the Operating Room 
Recovery of bowel function  Postoperative period till confirmation of bowel sounds 
Serum electrolytes  Baseline & at the end of surgery before shifting the patient out of the Operating Room 
Duration of hospital stay  Postoperative period till the discharge of the patient 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   16/07/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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)?  

Response - NO
Brief Summary  
Intraoperative fluid therapy is an important aspect of perioperative care in neonates undergoing laparotomy, as maintaining adequate fluid balance is crucial for optimal outcomes. 

-Liberal fluid therapy involves administering fluids more generously, often based on subjective clinical assessment and individual physician preferences. The aim is to ensure that the neonate has adequate circulating volume to maintain blood pressure and organ perfusion during surgery. This approach may involve administering fluids at a higher rate and/or larger volumes without strict adherence to specific hemodynamic targets. Advantages of liberal fluid therapy may include simplicity in application and rapid correction of hypovolemia if present. However, there are concerns associated with this approach. Excessive fluid administration can lead to fluid overload, which may result in edema, impaired organ function, and increased morbidity. Fluid overload can be particularly problematic in neonates, who have limited cardiovascular reserves.

-Goal-directed fluid therapy (GDFT) involves a more individualized and targeted approach to fluid administration. It aims to optimize hemodynamic parameters and tissue perfusion based on objective measures. GDFT involves continuous monitoring of specific parameters, such as central venous pressure (CVP), mean arterial pressure (MAP), cardiac output (CO), or stroke volume (SV), and plethysmograph variability index (PVI) to guide fluid administration. The goals typically focus on maintaining adequate cardiac output and oxygen delivery while avoiding fluid overload. Hemodynamic monitoring techniques such as arterial and central venous catheters, transesophageal Doppler, or non-invasive devices like PVI may be used to guide fluid therapy decisions. GDFT has been shown to be beneficial in various surgical settings, as it helps avoid both under- and over-resuscitation, optimizing fluid management and reducing complications. 

The Pleth Variability Index (PVI), is a dynamic and non-invasive parameter, which can be utilized to administer GDFT. This study aims to compare the volume of fluids infused using PVI-based GDFT with the conventional method of fluid administration in neonates undergoing emergency laparotomy. The postoperative metabolic and hematological profile and clinical outcomes like bowel movement, anastomotic leak and the duration of hospital stay will also be compared.
 
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