FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B999||Unspecified infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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

 
Close