| CTRI Number |
CTRI/2024/03/064270 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how calcium level in blood changes during major cancer surgeries, and its effects on blood-pressure-altering medicines. |
|
Scientific Title of Study
|
Ionized Calcium Levels and Intraoperative Vasopressor requirements during major cancer surgeries (iCaLIV) - a retrospective cohort study. |
| Trial Acronym |
iCaLIV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Shreyasi Ray |
| Designation |
Professor |
| Affiliation |
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex, MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre), Tata Memorial Centre Varanasi,
Sundarpur
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05426917700 |
| Fax |
|
| Email |
shreyasi@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Jyotirmay Kirtania |
| Designation |
Professor |
| Affiliation |
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi,
Sundarpur
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05426917700 |
| Fax |
|
| Email |
jyotirmay@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Professor Jyotirmay Kirtania |
| Designation |
Professor |
| Affiliation |
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi,
Sundarpur
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05426917700 |
| Fax |
|
| Email |
jyotirmay@mpmmcc.tmc.gov.in |
|
|
Source of Monetary or Material Support
|
| MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Center Varanasi |
|
|
Primary Sponsor
|
| Name |
MPMMCC Mahamana Pandit Madan Mohan Malviya Cancer CentreTata Memorial Centre Varanasi |
| Address |
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi Sundarpur, Varanasi, Uttar Pradesh, PIN 221005 |
| 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 |
| Prof Shreyasi Ray |
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre)Tata Memorial Centre Varanasi |
4th Floor OT Complex, MPMMCC, Tata Memorial Centre Varanasi, Sundarpur, PIN 221005
Varanasi
UTTAR PRADESH |
05426917700
shreyasi@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre Sundar Bagiya, Near Nariya Gate Banaras Hindu University Campus Varanasi Varanasi Uttar Pradesh |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a. All adult patients (age ≥ 18 years) who underwent major cancer surgery under general anesthesia at MPMMCC (Tata Memorial Centre Varanasi) between 1st January 2023 and 31st October 2023.
b. Patients for whom ionized calcium levels were measured by ABG (arterial blood gas analysis) during surgery as a part of standard of care. |
|
| ExclusionCriteria |
| Details |
a. Patients with incomplete medical records.
b. Patients who did not have ABG reports done intraoperatively as a part of standard of
care.
c. Patients with pre-existing calcium metabolism disorders.
d. Patients with concurrent surgical procedures not related to cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The incidence of ionized hypocalcemia in
patients undergoing major cancer surgery under general anesthesia. |
Baseline - intraoperative, when the attending anesthetist ordered ABG report for the first time during surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Intraoperative use of vasopressors
b. Total length of hospital stay within 30 days after the primary surgery including
re-admission stays |
a. The entire duration of surgery.
b. Day 30 after surgery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
05/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study aims to investigate the relationship between low levels of ionized calcium in the blood, known as ionized hypocalcemia, and the use of medications called vasopressors during major cancer surgeries. It is known from previously published studies that ionized hypocalcemia can significantly impact a patient’s heart function and blood circulation.
Our primary goal is to determine how frequently ionized hypocalcemia occurs in patients undergoing major cancer surgery under general anesthesia. Additionally, we seek to understand whether there is a connection between ionized hypocalcemia and the need for vasopressor medications during surgery under general anesthesia.
We will conduct this research by analyzing the medical records of patients who have undergone major cancer surgeries. Importantly, this means we won’t directly involve patients in any way, and we will strictly protect the privacy and confidentiality of their clinical data.
The societal benefits of this study include gaining a better understanding of how ionized calcium levels relate to heart function and blood circulation (hemodynamics) in patients during cancer surgery under general anesthesia, potentially leading to improved patient outcomes.
In summary, our objective is to determine the frequency of ionized hypocalcemia during cancer surgeries and how it correlates with the use of vasopressors during surgery under general anesthesia. This information could assist doctors and healthcare professionals in providing better care to patients during these critical surgeries under general anesthesia.
|