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CTRI Number  CTRI/2025/08/093323 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Blood pressure and intravascular fluid optimisation in elderly patients with hip fracture. A pilot study 
Scientific Title of Study   Use of non-invasive cardiac out monitoring for optimization of hemodynamic parameters versus standard care in geriatric patients with hip fractures undergoing surgery under spinal anaesthesia. A Pilot Study 
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 Abhishek Singh 
Designation  Assistant Professor 
Affiliation  AIIMS,NEW DELHI 
Address  Room no. 216, Department of Anesthesiology, Pain medicine and Critical care, Academic block, JPNATC, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  8287652624  
Fax    
Email  abhishek.aiims14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Singh 
Designation  Assistant Professor 
Affiliation  AIIMS,NEW DELHI 
Address  Room no. 216, Department of Anesthesiology, Pain medicine and Critical care, Academic block, JPNATC, AIIMS, NEW DELHI


DELHI
110029
India 
Phone  8287652624  
Fax    
Email  abhishek.aiims14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjishnujit Bandyopadhyay 
Designation  Assistant Professor 
Affiliation  AIIMS,NEW DELHI 
Address  Room no. 216, Department of Anesthesiology, Pain medicine and Critical care, Academic block, JPNATC, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  9779234688  
Fax    
Email  docbando@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar east, New Delhi, India, 110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  All India Institute of Medical Sciences, Ansari Nagar east, New Delhi, India, 110029 
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 
Abhishek Singh   All India Institute of Medical Sciences  Room no. 216, Department of Anesthesiology, Pain medicine and Critical care, Academic block,110029
South
DELHI 
8287652624

abhishek.aiims14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS,NEW DELHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment  Patient will be shifted to the OT table. Before induction of anesthesia patient will be monitored using 3 lead electrocardiogram, Pulse oximetry, non- invasive blood pressure and baseline values will be recorded. All fluid management and administration of inotrope or vasopressor therapy will be at the discretion of the anesthetist taking care of the patients. Ringer lactate solution will be used during the procedure. Post-operatively, investigator who will not be present in the theatre, and therefore blinded to the group allocation, will perform the follow-up visits to assess outcome measures. 
Intervention  Goal directed fluid therapy  Prior to induction of anesthesia, Noninvasive StarlingTM (Cheetah Medical Inc.TM) non-invasive hemodynamic monitor lead will be placed on the patient’s chest and abdomen and after calibration, baseline hemodynamic measurements will be taken (blood pressure, heart rate, stroke volume, cardiac output, cardiac index, stroke volume variation and pulse volume variation). After induction of anesthesia, measurement of hemodynamic parameters will be repeated. SVV of 13% will be taken as cutoff. The participant’s SVV will be optimized using 250 ml boluses of ringer lactate solution. Repeated boluses of ringer lactate solution will be given until a stroke volume variation  13% is no longer seen. Once the stroke volume variation is optimized, mean arterial blood pressure will be maintained to within 20% of baseline values using ephedrine bolus of 3mg. Data on stroke volume, SVV, PPV, CO, CI, heart rate, and blood pressure will be recorded at baseline, after induction of anesthesia and then every 15 minutes. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Aged 60 years or above
2. undergoing surgical repair of proximal femoral fracture.
 
 
ExclusionCriteria 
Details  1. age less than 60 year
2. polytrauma patients
3. revision hip surgery
4. undergoing total hip arthroplasty
5. Patients with severe left ventricular dysfunction
6. Cardiomyopathy with ejection fraction less than 40%.
7. HB less than 7 mg/dl
8. Severe pulmonary disease and liver disease.
9. Patient who refuse to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Length of stay in the hospital  at the time of discharge  
 
Secondary Outcome  
Outcome  TimePoints 
Post operative complications   till patient is admitted in the hospital 
ICU admission rate  in the postoperative period 
Length of ICU stay  till stay in the ICU 
Incidence of hypotension  Intraoperative period 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   15/09/2025 
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  

Hip fractures among the geriatric population are a major cause of morbidity and mortality, and the one-year mortality rate after hip fractures estimated to be as high as 30%. The worldwide annual incidence of hip fractures is estimated to be about 1.6 million and is expected to increase to 2.6 million by the year 2025 and 4.5 million by 2050 due to the aging population. The true figures on the incidence of hip fractures in India is lacking, though the annual incidence is estimated to be over 120 fractures per 100,000 persons over the age of 50, with higher rates in women.

Anesthetists play a very important role in the perioperative care of these patients. Intertrochanteric fractures carry distinctive challenges for the anesthetists as geriatric patients might harbor significant comorbidities, moreover, the incidence of these comorbidities has increased during the past years. After hip fracture, in-hospital mortality ranges from 2.3 to 13.9%, but the risk persists beyond the immediate surgical period with 6-month mortality rates ranging from 12 to 23%.Three in four hip fracture-associated deaths may be causally related to preexisting medical conditions rather than the fracture itself. This indicates that the hip fracture destabilizes a frail elderly population with a high burden of preexisting morbidities, thereby resulting in excess mortality. 

Many improvements have been introduced in the care of these patients, including improved surgical devices, earlier mobilization, prophylactic administration of antibiotics and anticoagulant, as well as increased rate of admission into rehabilitation unit. A careful preoperative assessment is usually recognized as essential in these patients to stabilize coexisting medical conditions and to optimize cardiovascular and respiratory functions. The anesthesiologist should distinguish the preoperative elements that required correction (dehydration, occult hypovolemia, anemia, hypoxia, electrolyte disturbances, and arrhythmias) and those that could modify the postoperative course of the patient (cognitive disorders, chronic cardiac, respiratory, and renal failure).

Various studies attempting to improve outcome through fluid optimization protocol has shown conflicting results. White et al demonstrated that the incidence of hypotension was significant with 56% of patients undergoing neck of femur (NOF) repair having a systolic blood pressure of less than 90 mmHg, and one third having a mean arterial pressure (MAP) of less than 55 mmHg.  Since intraoperative hypotension is associated with adverse events, optimization of hemodynamics using noninvasive cardiac output monitoring may be a valid treatment strategy in this group. Therefore, the aim of the study is to investigate the role of hemodynamic optimization in geriatric patients undergoing surgical repair of inter-trochanteric femoral fractures and the effects of this on length of stay. Secondary outcomes included post operative complications, ICU admission rate, the length of ICU stay, the incidence of hypotension and the use of vasopressors and fluids.

 
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