| 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
|
|
|
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
|
|
|
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. |