| CTRI Number |
CTRI/2020/12/029653 [Registered on: 09/12/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of dobutamine on renal resistive index in patients with sepsis |
|
Scientific Title of Study
|
Effect of dobutamine on renal resistive index in septic shock patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandava Venkata Sravani |
| Designation |
SENIOR RESIDENT |
| Affiliation |
DAYANAND MEDICAL COLLEGE & HOSPITAL |
| Address |
4th Floor ICU Block Department of Critical Care DMC& HOSPITAL TAGORE NAGAR CIVIL LINES LUDHIANA
Ludhiana PUNJAB 141001 India |
| Phone |
8297325094 |
| Fax |
|
| Email |
shravanichowdary5391@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gunchan Paul |
| Designation |
Associate Professor |
| Affiliation |
DAYANAND MEDICAL COLLEGE & HOSPITAL |
| Address |
4th floor ICU Block Department of Critical Care DMC& HOSPITAL TAGORE NAGAR CIVIL LINES LUDHIANA
Ludhiana PUNJAB 141001 India |
| Phone |
9878645330 |
| Fax |
|
| Email |
gunchan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mandava Venkata Sravani |
| Designation |
SENIOR RESIDENT |
| Affiliation |
DAYANAND MEDICAL COLLEGE & HOSPITAL |
| Address |
4th Floor ICU Block Department of Critical Care DMC& HOSPITAL TAGORE NAGAR CIVIL LINES LUDHIANA
Ludhiana PUNJAB 141001 India |
| Phone |
8297325094 |
| Fax |
|
| Email |
shravanichowdary5391@gmail.com |
|
|
Source of Monetary or Material Support
|
| DAYANAND MEDICAL COLLEGE & HOSPITAL, LUDHIANA |
|
|
Primary Sponsor
|
| Name |
DAYANAND MEDICAL COLLEGE HOSPITAL |
| Address |
DEPT OF CRITICAL CARE, DAYANAND MEDICAL COLLEGE & HOSPITAL, TAGORE NAGAR, CIVIL LINES, LUDHIANA, PUNJAB 141001 |
| Type of Sponsor |
Private 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 |
| M V SRAVANI |
DAYANAND MEDICAL COLLEGE & HOSPITAL |
4th Floor ICU Block Department of Critical Care DAYANANAD MEDICAL COLLEGE AND HOSPITAL, TAGORE NAGAR, CIVIL LINES, LUDHIANA Ludhiana PUNJAB |
8297325094
shravanichowdary5391@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to ICU under Critical Care Medicine with septic shock requiring vasopressors to maintain MAP>65 mm Hg and lactate ≥2 despite adequate fluid resuscitation. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years or older than 65 years.
2. AKI on renal replacement therapy (RRT) or with an expectation of RRT within 24 hours.
3. Known case of renal artery stenosis, chronic kidney disease defined by a glomerular filtration rate of less than 30mL/min/1.73m2.
4. Cirrhosis with hepatorenal syndrome
5. Use of renin-angiotensin-aldosterone antagonists
6. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of dobutamine on Renal Resistive Index in patients with septic shock. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the relationship of RRI with lactate in septic shock.
2. To assess the relationship of RRI with AKI in septic shock.
|
48 hours |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/12/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: Septic shock is defined as “subset of sepsis with circulatory and cellular/metabolic dysfunction associated with higher risk of mortality.†After appropriate resuscitation if MAP does not improve to about 65 mm Hg it is recommended that vasopressors be initiated. Norepinephrine is recommended as the initial vasopressor as per Surviving Sepsis campaign recommendations. It is recommended to use second vasopressor to reduce the dose of first considering side effects of high dose of norepinephrine. Second choice is always so far based on clinical judgement and arbitrary between epinephrine, vasopressin and dobutamine. However none of the above vasopressors were proven to be strongly beneficial after Nor-Epinephrine and no definitive strong recommendations were made regarding the second choice of vasopressor. Renal Resistive Index (RRI) is a sonographic measurement of resistance to flow in intrarenal arcuate or interlobar arteries. An inverse relationship between MAP and RRI has been strongly demonstrated. Owing to the
lacunae in the second choice vasopressor, this study aims at using Doppler RRI
as a surrogate marker and early index of hypoperfusion and assist the choice of
vasopressor in septic shock. The secondary aim is to assess the relationship of
RRI to AKI and lactate in septic shock. Aim of Study: Primary objective: To evaluate
the effect of dobutamine on Renal Resistive Index in patients with septic shock. Secondary objective: 1. To assess
the relationship of RRI with lactate in septic shock. 2. To assess
the relationship of RRI with AKI in septic shock. Study Protocol: All patients of septic shock in ICU
included in the study will be resuscitated according to SSC guidelines.
Patients with septic shock will initially be resuscitated with crystalloids to
maintain a MAP ≥65 mm Hg. The adequacy of fluid
resuscitation is monitored by CVP (8-12 mm Hg), PPV (<13%) and PLR test. Following adequate resuscitation, if the MAP still remains less than 65 mm Hg
then nor- epinephrine will be used as the first line vasopressor. Nor-epinephrine
infusion will be started at a dose of 0.05μg/kg/min and gradually increased to
0.2μg/kg/min. Once the mean
arterial pressure (MAP) is >65 mm Hg will be started on dobutamine at a dose
of 3μg/kg/min. In case if MAP falls below 65 mm Hg despite the
above ionotropic support, vasopressin will be added as rescue drug in a dose
upto 0.03U/min.
The response
to vasopressors / ionotropes and resuscitation will be monitored by vital
parameters such as heart rate, MAP, CVP, ejection fraction (EF), ScvO2 and
urine output. Lactate and RRI will be measured at admission, 1-hr, 6-hrs,
12-hrs, 24-hr and 48-hrs following start of ionotropes. S.Creatinine is
measured every day for 72 hours. SOFA score will be measured everyday. Clinical Significance: This will guide the effect of dubutamine in septic shock patients by using RRI as a monitoring tool for organ perfusion. Keywords: Septic shock, Renal Resistive Index, Dobutamine |