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