| CTRI Number |
CTRI/2018/05/013964 [Registered on: 18/05/2018] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to know the safety and effectiveness of blood pressure supporting and brain pressure reducing drugs through the smaller peripheral veins |
|
Scientific Title of Study
|
Effectiveness of peripheral intravenous line in administering vasoactive medications and hypertonic saline infusion in critically ill patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Kumar |
| Designation |
FNB Critical Care Resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
House no. 9, 3rd floor
Anand Nagar Main Road
AGS Colony
Near Atria Institute Of Technology
Anand Nagar, Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9920171486 |
| Fax |
|
| Email |
prammcian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Menon |
| Designation |
Consultant Intensivist |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Head of the department
Intensive Care Unit
Bangalore Baptist Hospital
Hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9901744844 |
| Fax |
|
| Email |
indiramenon@hotmail.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar |
| Designation |
FNB Critical Care Resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
House no. 9, 3rd floor
Anand Nagar Main Road
AGS Colony
Near Atria Institute Of Technology
Anand Nagar, Hebbal
KARNATAKA
560024
India |
| Phone |
9920171486 |
| Fax |
|
| Email |
prammcian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital
Bellary Road, Vinayaknagar,
Hebbal, Bangalore, Karnataka
560024 |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bellary Road, Vinayakanagar,
Hebbal, Bengaluru,
Karnataka, 560024 |
| 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 Prashant Kumar |
Bangalore Baptist Hospital |
Critical Care Department
Intensive Care Unit
Ground Floor, Room no. 123
Bangalore Baptist Hospital
Vinayak Nagar, Hebbal
Bangalore
KARNATAKA |
9920171486
prammcian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Hospital Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients more than 18 years of age admitted to ICU requiring single Vasoactive medication or hypertonic saline through Peripheral Intravenous line., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
No comparator agents |
| Intervention |
Noradrenaline
Dopamine
3% Saline |
Single Vasoactive medication either noradrenaline ( Concentration 50 mcg/ml, Dose upto 0.2 mcg/kg/min ), or dopamine ( Concentration 5 mg/ml, Dose upto 10 mcg/kg/min ) as applicable
or 3% Saline (concentration undiluted, dose upto 30 ml/hour)
Frequency: As continuous intravenous infusion
Route for administration: Via peripheral intravenous line
Total duration of therapy: Depending on the clinical improvement or need for central venous catheter insertion ( either because of extravasation or because of increase in dose of this drugs then the set maximum rate) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years of age admitted to ICU requiring single vasoactive medications or 3% Saline through Peripheral Intravenous line with either Mean arterial pressure (MAP) < 65 mmHg or Systolic blood pressure (SBP) < 90 mmHg or Cerebral oedema or raised ICP
|
|
| ExclusionCriteria |
| Details |
Patients already having Central Venous Catheter access. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of peripheral intravenous (PIV) line in administering vasoactive medications and hypertonic saline infusion in critically ill patients. |
After stopping infusion through the peripheral intravenous line ( It can either be after clinical improvement or death or central venous catheter placement ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reason for insertion of central venous catheter access
Total time of infusion to develop extravasation and its association with site and size of peripheral intravenous line |
After central venous catheter placement or After development of extravasation needing either change in site of peripheral line or need for central venous access |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "208"
Final Enrollment numbers achieved (India)="208" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vasoactive medications (VM) and
hypertonic saline infusion are indicated in most of intensive care unit (ICU)
patients. Both are usually recommended to be infused through central
venous catheter (CVC) access, as the infusion through Peripheral Intravenous
(PIV) line can cause local tissue injury due to extravasation of the drug.
However insertion of CVC access itself is associated with complications
including risk of bleeding, embolism, pneumothorax, catheter related blood
stream infections etc. CVC access also adds to the increased cost during ICU
stay and delay in initiating treatment. In our ICU, we usually start with PIV
line and we do not encounter problems. In this study, we
hypothesise that VM and 3% S infusion is feasible and safe through peripheral
intravenous route in lower concentrations and we want to conduct this
prospective observational study for confirmation of this hypothesis. |