Liver CirrhosisNCT04437810
To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development
A study testing Albumin and Standard Medical Treatment in people with Liver Cirrhosis and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined , which decreases the morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Acute Kidney Injury
- What is being tested?
- Albumin and Standard Medical Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 8 Jul 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are above 18 years of age
- Patients with Cirrhosis and SBP (community acquired /Health care associated/ nosocomial) with baseline Creatinine <1mg/dl, Bilirubin <4mg/dl
Who cannot join
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known Chronic Kidney Disease or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV infection;
- GI bleed within 1 month before the study
Show all 13Show fewer
- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- Serum Bilirubin ≥4 mg/dL and Serum Creatinine ≥ 1 mg/dl at presentation
- Patients requiring Albumin for any other indication.
- Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Venishetty Shantan, MD, 01146300000, venishantan@gmail.com
About this study
Official title: To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development - A Randomised Placebo Controlled Trial- A Pilot Study
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined , which decreases the morbidity and mortality. But the role of Albumin in patient with SBP who are at low risk of AKI development (Serum Bilirubin <4mg/dl, Creatinine <1mg/dl at the time of presentation) has been controversial and there are no placebo controlled trials. We propose that Albumin at the standard doses is beneficial in preventing development of AKI in patients with SBP who are at low risk of AKI development.
Read the detailed description
- Aim- To compare the efficacy of albumin when compared to placebo in the development or progression of AKI in patients with cirrhosis and spontaneous bacterial peritonitis who are at low risk for AKI development (i.e Serum Bilirubin <4 mg/dL and serum creatinine < 1 mg/dl at presentation)
- Primary objective: To evaluate the Proportion of patients developing AKI by day 7
- Secondary objectives:
- To compare the resolution of SBP by day 2 and day 5 in both the groups
- To measure the Changes in PRA, TNF-α, IL-6 at day 7
- To measure the Changes in renal resistive index at day 7
- To compare Mortality by day 7 and 28 in both the groups
- Methodology:
- Dose and duration of albumin/placebo infusion in both the limbs: -The dose of albumin was 1.5 g/kg of body weight given within 6 h of SBP being diagnosed over a period of 12hrs, followed by an additional infusion of 1.0 g/kg on day 3 over a period of 12 hrs. Other arm receives a similar quantity of isotonic fluid like normal saline or plasmalyte
- Renal resistive index will be done with the help of a) high frequency probe(5Mhz) together with the use of color or power Doppler to help vessel localization., sampling for RRI should be done at the level of the arcuate or interlobar arteries, adjacent to medullary pyramids. Measurements will be repeated in different parts of both organs (superior, median, and lower) when at least three reproducible waveforms have been obtained. An RRI will be calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and the mean value of three measurements at each kidney will be considered. An RRI value 0.60 ± 0.01 (mean ± SD) is usually taken as normal with a value of 0.70 being considered the upper normal threshold by most authors. In order to maximize waveform size, care will be taken in using the lowest pulse repetition frequency without aliasing, the highest possible gain without noise and the lowest wall filter. Patient will undergo RRI on day 0 and day 7.
- PRA, TNF-A and IL-6: - Measurement at day 0 and day 7 PRA is measured by generating AngI (angiotensin I) from endogenous angiotensinogen, followed by measurement by RIA of the generated AngI. Although PRA measurement is convenient for estimating the biological activity of the renin system, it may not necessarily reflect the real concentration of active renin. Il-6 is measured with the help of IL-6 ELISA kits. TNF- alpha is measured using flow cytometry.
- Antibiotics to be used in the SBP: - The gold standard treatment consists of third-generation cephalosporins, especially cefotaxime/ceftriaxone, given intravenously at a dose of 4-8 g/d for a minimum duration of 5 d. (AASLD guidelines). If patient does not respond then switch over to carbapenem (meropenem) with or without tigecycline. if patient still does not respond then GM-CSF will be given.
- Blood samples and Ascitic fluid samples will be collected and stored for measurement of Neutrophilic activity (CD66+/CD66-, CD11b) and Macrophage activity (CD 14+, CD 16+, IL-6, TNF-α)
- Serum Cystatin C and Urinary NGAL, markers and predictors of renal injury will be measured in both the limbs. Management of the complications: -
- The patients who develop sepsis (presence of SIRS; positive blood cultures); worsening of hepatic encephalopathy >2 grades, variceal bleed or deterioration of the clinical condition; worsening of AKI and volume overload will be managed according to standard protocols,
- Definitions: -
- Spontaneous bacterial peritonitis: - SBP was diagnosed when the ascitic fluid polymorphonuclear (PMN) cell count was > 250 cells/mm3.
- Resolution of Spontaneous bacterial peritonitis: - A repeat diagnostic paracentesis to document the response by a greater-than 25% decrease in ascitic fluid neutrophil count at 48 h after initiation of antibiotics is recommended Study population: Patients with Cirrhosis of Liver who presents with Spontaneous Bacterial Peritonitis with baseline creatinine <1mg/dl and Serum Bilirubin <4mg/dl Study Design: Single Center, Double Blinded (Patient and Treating physician), Placebo Controlled (Saline), Randomised Controlled Trial- a pilot study Study period: 1.5 year from the date of ethics approval (2020-2022) Sample size with justification: The study will be conducted as a pilot study and all the cases with SBP with low risk for AKI development will be recruited. The minimum number of subjects expected to be enrolled is 100. Intervention:
- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with Standard medical therapy
- Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy
- Monitoring and assessment: This RCT will be conducted at ILBS New Delhi The following data will be recorded for each patient:
- Etiology of cirrhosis, duration, Large volume paracentesis
- H/o of jaundice, distension abdomen, swelling feet, altered sensorium, vomiting of blood or passing melena
- Height, weight and BMI
- Investigations: CBC, LFT, PT/INR, KFT.
- Disease severity (CTP and MELD scores)
- Day 0 - Hemogram, prothrombin time/ INR, KFT, LFT, TNF alpha,IL-6, PRA, ABG, blood culture, urine culture, chest X-ray, urine R/M, ascitic fluid analysis for the TLC, DLC, sugar, protein, albumin, culture, gram stain and Urine NGAL and Serum cystatin C ,Renal Resistive Index(RRI) will be done and ECG, ECHO for the volume overload, IVC diameter.
- DAY 2 - hemogram, KFT, LFT, ABG, chest X-ray, and ascitic fluid analysis for the TLC, DLC, culture, gram stain
- DAY 7: - PRA, TNF-alpha, IL-6
- DAY 7: - Renal Resistive Index,
- Day 28-- hemogram, prothrombin time/ INR, KFT, LFT
- Statistical Analysis:
- Continuous variables- Mean +/- SD
- Categorical variables as percentages (%) or Frequencies
- Student t test will be applied in continuous data compared with two groups
- Survival analysis like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors responsible for mortality
- Besides these, Intent to treat (ITT) and Per Protocol (PP) will be done at the time of data analysis. Adverse effects:
- Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea Wheezing, Volume overload, Anaphylactic reaction
- Stopping rule of study:
- In Albumin arm
- Development of AKI
- Adverse reaction to drug
- Cardiopulmonary compromise
- In Placebo Arm
- Development of AKI
- Development of Septic Shock
- Conditions
- Liver Cirrhosis, Acute Kidney Injury
- Being tested
- Albumin, Standard Medical Treatment
- Medical subject headings
- Liver Cirrhosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminBiological
- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3)
Standard Medical TreatmentOther
standard medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Albumin+ SMT | Experimental | Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with standard medical therapy Receives: Biological: Albumin; Other: Standard Medical Treatment |
| Placebo+SMT | Placebo comparator | - Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having development / progression of Acute Kidney Injury in both groups.
Measured: Day 7
Secondary outcomes (8)
Resolution of Spontaneous Bacterial Peritonitis in both groups
Ascitic fluid absolute neutrophil count < 250
Measured: Day 2
Resolution of Spontaneous Bacterial Peritonitis in both groups
Ascitic fluid absolute neutrophil count < 250
Measured: Day 7
Change in PRA in both groups
Measured: Day 7
Change in TNF-alpha in both groups
Measured: Day 7
Change in IL-6 in both groups
Measured: Day 7
Change in Renal resistive index in both groups
Measured: Day 7
Mortality in both groups
Measured: Day 7
Mortality in both groups
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start8 Jul 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437810
- Sponsor's protocol ID
- ILBS-Cirrhosis-31
- Status last verified
- Jan 2022
- First submitted
- 15 Jun 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development - A Randomised Placebo Controlled Trial- A Pilot Study
- ClinicalTrials.gov ID
- NCT04437810
- Acronym / sponsor ID
- ILBS-Cirrhosis-31
- Conditions
- Liver Cirrhosis, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined , which decreases the morbidity and mortality. But the role of Albumin in patient with SBP who are at low risk of AKI development (Serum Bilirubin <4mg/dl, Creatinine <1mg/dl at the time of presentation) has been controversial and there are no placebo controlled trials. We propose that Albumin at the standard doses is beneficial in preventing development of AKI in patients with SBP who are at low risk of AKI development.
Detailed description
- Aim- To compare the efficacy of albumin when compared to placebo in the development or progression of AKI in patients with cirrhosis and spontaneous bacterial peritonitis who are at low risk for AKI development (i.e Serum Bilirubin <4 mg/dL and serum creatinine < 1 mg/dl at presentation)
- Primary objective: To evaluate the Proportion of patients developing AKI by day 7
- Secondary objectives:
- To compare the resolution of SBP by day 2 and day 5 in both the groups
- To measure the Changes in PRA, TNF-α, IL-6 at day 7
- To measure the Changes in renal resistive index at day 7
- To compare Mortality by day 7 and 28 in both the groups
- Methodology:
- Dose and duration of albumin/placebo infusion in both the limbs: -The dose of albumin was 1.5 g/kg of body weight given within 6 h of SBP being diagnosed over a period of 12hrs, followed by an additional infusion of 1.0 g/kg on day 3 over a period of 12 hrs. Other arm receives a similar quantity of isotonic fluid like normal saline or plasmalyte
- Renal resistive index will be done with the help of a) high frequency probe(5Mhz) together with the use of color or power Doppler to help vessel localization., sampling for RRI should be done at the level of the arcuate or interlobar arteries, adjacent to medullary pyramids. Measurements will be repeated in different parts of both organs (superior, median, and lower) when at least three reproducible waveforms have been obtained. An RRI will be calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and the mean value of three measurements at each kidney will be considered. An RRI value 0.60 ± 0.01 (mean ± SD) is usually taken as normal with a value of 0.70 being considered the upper normal threshold by most authors. In order to maximize waveform size, care will be taken in using the lowest pulse repetition frequency without aliasing, the highest possible gain without noise and the lowest wall filter. Patient will undergo RRI on day 0 and day 7.
- PRA, TNF-A and IL-6: - Measurement at day 0 and day 7 PRA is measured by generating AngI (angiotensin I) from endogenous angiotensinogen, followed by measurement by RIA of the generated AngI. Although PRA measurement is convenient for estimating the biological activity of the renin system, it may not necessarily reflect the real concentration of active renin. Il-6 is measured with the help of IL-6 ELISA kits. TNF- alpha is measured using flow cytometry.
- Antibiotics to be used in the SBP: - The gold standard treatment consists of third-generation cephalosporins, especially cefotaxime/ceftriaxone, given intravenously at a dose of 4-8 g/d for a minimum duration of 5 d. (AASLD guidelines). If patient does not respond then switch over to carbapenem (meropenem) with or without tigecycline. if patient still does not respond then GM-CSF will be given.
- Blood samples and Ascitic fluid samples will be collected and stored for measurement of Neutrophilic activity (CD66+/CD66-, CD11b) and Macrophage activity (CD 14+, CD 16+, IL-6, TNF-α)
- Serum Cystatin C and Urinary NGAL, markers and predictors of renal injury will be measured in both the limbs. Management of the complications: -
- The patients who develop sepsis (presence of SIRS; positive blood cultures); worsening of hepatic encephalopathy >2 grades, variceal bleed or deterioration of the clinical condition; worsening of AKI and volume overload will be managed according to standard protocols,
- Definitions: -
- Spontaneous bacterial peritonitis: - SBP was diagnosed when the ascitic fluid polymorphonuclear (PMN) cell count was > 250 cells/mm3.
- Resolution of Spontaneous bacterial peritonitis: - A repeat diagnostic paracentesis to document the response by a greater-than 25% decrease in ascitic fluid neutrophil count at 48 h after initiation of antibiotics is recommended Study population: Patients with Cirrhosis of Liver who presents with Spontaneous Bacterial Peritonitis with baseline creatinine <1mg/dl and Serum Bilirubin <4mg/dl Study Design: Single Center, Double Blinded (Patient and Treating physician), Placebo Controlled (Saline), Randomised Controlled Trial- a pilot study Study period: 1.5 year from the date of ethics approval (2020-2022) Sample size with justification: The study will be conducted as a pilot study and all the cases with SBP with low risk for AKI development will be recruited. The minimum number of subjects expected to be enrolled is 100. Intervention:
- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with Standard medical therapy
- Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy
- Monitoring and assessment: This RCT will be conducted at ILBS New Delhi The following data will be recorded for each patient:
- Etiology of cirrhosis, duration, Large volume paracentesis
- H/o of jaundice, distension abdomen, swelling feet, altered sensorium, vomiting of blood or passing melena
- Height, weight and BMI
- Investigations: CBC, LFT, PT/INR, KFT.
- Disease severity (CTP and MELD scores)
- Day 0 - Hemogram, prothrombin time/ INR, KFT, LFT, TNF alpha,IL-6, PRA, ABG, blood culture, urine culture, chest X-ray, urine R/M, ascitic fluid analysis for the TLC, DLC, sugar, protein, albumin, culture, gram stain and Urine NGAL and Serum cystatin C ,Renal Resistive Index(RRI) will be done and ECG, ECHO for the volume overload, IVC diameter.
- DAY 2 - hemogram, KFT, LFT, ABG, chest X-ray, and ascitic fluid analysis for the TLC, DLC, culture, gram stain
- DAY 7: - PRA, TNF-alpha, IL-6
- DAY 7: - Renal Resistive Index,
- Day 28-- hemogram, prothrombin time/ INR, KFT, LFT
- Statistical Analysis:
- Continuous variables- Mean +/- SD
- Categorical variables as percentages (%) or Frequencies
- Student t test will be applied in continuous data compared with two groups
- Survival analysis like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors responsible for mortality
- Besides these, Intent to treat (ITT) and Per Protocol (PP) will be done at the time of data analysis. Adverse effects:
- Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea Wheezing, Volume overload, Anaphylactic reaction
- Stopping rule of study:
- In Albumin arm
- Development of AKI
- Adverse reaction to drug
- Cardiopulmonary compromise
- In Placebo Arm
- Development of AKI
- Development of Septic Shock
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin+ SMT | Experimental | Biological: Albumin, Other: Standard Medical TreatmentPatients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with standard medical therapy |
| Placebo+SMT | Placebo comparator | Other: Standard Medical Treatment- Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are above 18 years of age
- Patients with Cirrhosis and SBP (community acquired /Health care associated/ nosocomial) with baseline Creatinine <1mg/dl, Bilirubin <4mg/dl
Key exclusion criteria (13 listed)
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known Chronic Kidney Disease or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) | Biological | Albumin+ SMT |
| Standard Medical Treatmentstandard medical therapy | Other | Albumin+ SMT, Placebo+SMT |
Primary outcome
Proportion of patients having development / progression of Acute Kidney Injury in both groups.
Time frame: Day 7
8 secondary outcomes
Resolution of Spontaneous Bacterial Peritonitis in both groups
Time frame: Day 2
Resolution of Spontaneous Bacterial Peritonitis in both groups
Time frame: Day 7
Change in PRA in both groups
Time frame: Day 7
Change in TNF-alpha in both groups
Time frame: Day 7
Change in IL-6 in both groups
Time frame: Day 7
Change in Renal resistive index in both groups
Time frame: Day 7
Mortality in both groups
Time frame: Day 7
Mortality in both groups
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin and Standard Medical Treatment in people with Liver Cirrhosis and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Venishetty Shantan, MD (01146300000, venishantan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having development / progression of Acute Kidney Injury in both groups. (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.