| CTRI Number |
CTRI/2025/09/095373 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To predict the fall in blood pressure after giving general anaesthesia by measurement of size of vein in the abdomen with ultrasound before operation in patients with kidney failure on dialysis. |
|
Scientific Title of Study
|
Evaluation of the role of preoperative inferior venacava collapsibility index to predict hypotension after induction of general anaesthesia in end stage renal disease patients on maintenance hemodialysis undergoing non cardiac surgery- A prospective observational 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 |
Dara vanaja |
| Designation |
Junior Resident |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad |
| Address |
Room 7,SPECIALITY BLOCK OT,3rd floor,Department of Anaesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad -500082,India
Hyderabad
TELANGANA
500082
India |
| Phone |
9059794224 |
| Fax |
|
| Email |
daravanaja697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad |
| Address |
Room no:1,SPECIALITY BLOCK OT,3rd floor,Department of Anaesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad -500082,India
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
Indiradevraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad |
| Address |
Room no:1,SPECIALITY BLOCK OT,3rd floor,Department of Anaesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad -500082,India
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
Indiradevraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Intensive Care, Nizams Institute of Medical Sciences,Punjagutta,Hyderabad-500082,India |
| 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 |
| Dr Dara vanaja |
Nizams Institute of Medical Sciences |
Room 7,SPECIALITY BLOCK OT,3rd floor,Department of Anaesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad -500082,India
Hyderabad
TELANGANA |
9059794224
daravanaja697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Measuring of Pre operative IVCCI |
IVCCI Predicts hypotension ater induction of GA in ESRD Patients on MHD. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Greater than 18 years 2.Patients of either sex 3.Patients with BMI less than 35kg per m2 4.Patients who have given a written and valid consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria 1.Patient refusal 2.Suspected difficult airway 3.Chronic obstructive pulmonary disease (COPD), 4.Elevated systolic pulmonary arterial pressure (more than 40 mmHg), 5.Depressed left ventricular function (EF less than 40%), 6.Any pathology which can increase intra abdominal pressure such as ascites, pregnancy. 7.Withdrawal criteria will be poor ultrasound IVC visualization or prolonged intubation attempt (More than 30s). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the preoperative IVCCI% that predicts hypotension after induction of GA in ESRD patients on maintenance HD undergoing noncardiac surgery. |
Baseline value and at any time after induction of GA until 15 mins after endotracheal intubation and before the start of any surgical manipulations.
If hypotension occurred, blood pressure will be measured every 3 min until hypotension subsides. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate IVC diameter and, IVCCI with the duration between HD and induction of GA in these patients. |
Before induction |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/11/2025 |
| 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="1"
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
|
The USG guided IVC diameter and IVCCI measurement is an easy,non invasive and attractive option to identify patients at risk of developing low blood pressure after induction of GA.This is a research undertaken to study the usefulness of IVC Diameter and IVCCI in patients with kidney failure. Patients will be clearly explained about the procedure and informed consent will be taken.The IVCCI will be measured and baseline vitals are noted then patient will be given GA.Hypotension will be defined as fall in systolic bp by more than 30% from baseline.Fluids ringer lactate 4ml/kg/hr is given f/b vasopressors if needed. |