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CTRI Number  CTRI/2024/12/078062 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to Compare targeted Fluid therapy with liberal Fluid Therapy in Adults Undergoing Major Emergency Surgery" 
Scientific Title of Study   Pulse pressure variation guided goal-directed fluid therapy versus liberal fluid therapy in adult patients undergoing major emergency surgery: A 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  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Department of Trauma and Emergency Medicine AIIMS Kalyani NH-34 connector Basantapur Saguna Nadia

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Department of Trauma and Emergency Medicine AIIMS Kalyani NH-34 connector Basantapur Saguna Nadia

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Department of Trauma and Emergency Medicine AIIMS Kalyani NH-34 connector Basantapur Saguna Nadia

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, Nadia, West Bengal 741245, India 
 
Primary Sponsor  
Name  AIIMS Kalyani 
Address  Department of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, Nadia, West Bengal, 741245 
Type of Sponsor  Government medical college 
 
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 Roshan Andleeb  AIIMS Kalyani  Department of Trauma and Emergency Medicine
Nadia
WEST BENGAL 
9045292647

roshan8978@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  liberal fluid therapy   after induction of general anaesthesia patients will receive a balanced crystalloid solution (Plasmalyte) as per the Holliday–Segar 4-2-1 rule, along with the conventional method of calculating cumulative losses accounting for vasodilation due to anaesthesia, estimated blood loss, and urine output every hour. Mean arterial pressure 70 mmHg and diuresis 0.5 mL/kg/hr will be maintained, If the fluid regimen does not achieve these goals, vasopressors will be administered to maintain a mean arterial pressure 70 mmHg. Blood transfusions will be carried out as per the maximal allowable blood loss. 
Comparator Agent  pulse pressure variation guided goal-directed fluid therapy  patients will receive the same crystalloid to keep their PPV higher than 12%. Mean arterial pressure 70 mmHg and diuresis 0.5 mL/kg/hr will be maintained, If the fluid regimen does not achieve these goals, vasopressors will be administered to maintain a mean arterial pressure 70 mmHg. Blood transfusions will be carried out as per the maximal allowable blood loss. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA (American Society of Anesthesiologists) physical status I-IV

Major emergency surgery (including abdominal, thoracic, and pelvic surgery)- for example, surgery for Gastrointestinal perforation/ obstruction, obstructed hernia, appendicitis/Cholecystitis with sepsis/localised peritonitis, abdominal sepsis, Fournier/Maloney gangrene, necrotising fasciitis, penetrating/blunt trauma abdomen with solid organ injury or hollow viscera injury, Necrotising hemorrhagic pancreatitis, Thoracic empyema/ fungal infections, thoracic trauma, bronchopleural fistula grade II-IV air leak, Liver abscess, etc.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sequential Organ Failure
Assessment (SOFA) score  
preoperative
postoperative- day1, day 3 and day 5 
 
Secondary Outcome  
Outcome  TimePoints 
serum lactate:   preoperative, end of surgery or extubation and at first, second and fifth day 
Serum albumin:   preoperative, first, second and fifth day 
C-reactive protein:   preoperative, first, second fifth day 
fluid balance, hypotension episode and vasopressor usage  intraoperative period 
Post-operative surgery-related complications, pulmonary, renal, cardiovascular and haematological complications and postoperative infection.  postoperative period 
All-cause mortality during the longest follow-up period.
 
postoperative  
Length of hospital stay (hospital LOS) in days  postoperative 
Vasopressor or inotrope administration during the longest follow-up period to correct haemodynamic instability  postoperative  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   21/12/2024 
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="2"
Months="0"
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  

Background: Optimal intraoperative fluid management significantly improves postoperative outcomes, particularly in major surgeries. Fluid management in emergency surgeries is more challenging than in elective settings as mortality risk is approximately eightfold higher.  Widely used liberal fluid therapy (LFT), can lead to complications like fluid overload. Goal-directed fluid therapy (GDFT) is effective but often invasive and costly. Pulse Pressure Variation (PPV)-guided GDFT offers a minimally invasive and cost-effective alternative with the potential to reduce postoperative complications.

Objective: This study aims to compare the impact of intraoperative PPV-guided GDFT with conventional LFT on postoperative outcomes in adult patients undergoing major emergency surgeries.

Methods:

This single-centre, randomized, controlled, triple-blind, parallel-arm trial will be conducted at AIIMS Kalyani. A total of 62 patients will be randomly assigned to two groups (PPV-GDFT or LFT) in a 1:1 ratio using a computer-generated randomization table. Allocation will be concealed using sequentially numbered, sealed envelopes.

Inclusion criteria: Adults (18–65 years), ASA grades I–IV, undergoing emergency major surgeries under general anaesthesia.

Exclusion criteria: Patients presenting with bleeding emergencies requiring immediate life-saving surgical intervention, resuscitative laparotomy, ED thoracotomy, post-cardiac arrest status, Neurological emergency, Pregnancy, burn injuries, ASA V category, acute liver failure, Known coagulopathy or on anticoagulant therapy (unmanageable in a perioperative setting), Pre-existing severe cardiac dysfunction (ejection fraction <30%, severe cardiac arrhythmia, severe valvular disease, intracardiac shunt) and  Patients with terminal cancer needing palliative surgery or receiving regular renal replacement therapy.

Intervention:

LFT group: Balanced crystalloid (Plasmalyte) based on the Holliday–Segar formula, with adjustments for cumulative losses, blood loss, and urine output.

PPV-GDFT group: Balanced crystalloid to maintain PPV >12%.

In both groups, mean arterial pressure (MAP) >70 mmHg and urine output >0.5 mL/kg/hr will be maintained, with vasopressors administered if necessary.

Postoperative management will include maintaining urine output >0.5 mL/kg/hr and MAP >70 mmHg until patients resume oral intake. Excessive fluid balance (>1 L) will be managed with furosemide.

 

Outcomes: 

Primary outcome: Postoperative Sequential Organ Failure Assessment (SOFA) scores on days 1, 2, and 5.

Secondary outcomes: Intraoperative fluid balance, hypotension episodes, vasopressor use, postoperative serum lactate, serum albumin, C-reactive protein, complications (surgical/non-surgical), length of hospital stay, and mortality.

Statistical Analysis:

Data will be collected using a paper-based case report form and entered into Excel. Continuous data will be analyzed using Mann–Whitney or Student’s t-tests, and categorical data with Fisher’s exact test. Statistical significance will be set at P < 0.05.

Conclusion: This trial will assess whether PPV-guided GDFT provides superior outcomes compared to conventional LFT in major emergency surgeries.

 
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