Cardiorenal SyndromePhase 2DOMICASNCT02644057
Dobutamaine Versus Milrinone in Cardiorenal Syndrome
A Phase 2 study testing Milrinone and Dobutamine in people with Cardiorenal Syndrome, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cardiorenal Syndrome
- What is being tested?
- Milrinone and Dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- Phase
- Phase 2
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Admitted to the hospital with a primary diagnosis of Decompensated Heart Failure
- Onset of cardio-renal syndrome (increasing creatinine>0.3mg/dl) after or before hospitalization. After hospitalization within 7 days of from the time of admission after receiving intravenous diuretics and heart failure medication optimization. Before hospitalization in the setting of escalating doses of outpatient loop diuretics and heart failure medication optimization
- Persistent volume overload- For patients with a pulmonary artery catheter, peristent volume overload will include :
- Pulmonary capillary wedge pressure >22mm Hg and one of the following clinical signs :2+ peripheral edema and/or pulmonary edema or pleural effusion on chest Xray. For patients without a pulmonary artery catheter- persistent volume overload will include atleast 2 of the following: 2+ peripheral edema , jugular venous pressure >10 mm Hg and pulmonary edema or pleural effusion on chest Xray
- BNP>400
- Cr-1.2-3.0
Who cannot join
- Intravascular volume depletion
- Acute coronary syndrome within 4 weeks
- Indication for hemodialysis
- Systolic Blood pressure <90mm Hg or MAP<60mm Hg at the time of enrollment
- Alternate explanation for worsening renal function , such as obstructive nephropathy , contrast induced nephropathy , ATN
- Clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic drugs
- The use of iodinated radio-contrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization
- Underlying rhythm disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dobutamine Versus Milrinone for Renal Recovery in Patients With Cardiorenal Syndrome-A Prospective Cohort Study in Patients With Acute Decompensated Heart Failure
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more. Chronic heart failure is one of the most life threatening cardiovascular disorder thought to affect nearly six million US population with 600,000 new cases every year. The heart is responsible for perfusion to all vital organs including kidneys and dysfunction in either affects both the vital organs. When dysfunction of heart leads to dysfunction of kidneys or vice versa it is referred to as cardio renal syndrome (CRS). The underlying pathophysiology for CRS has been poorly understood and considered multifactorial. Worsening renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is associated with greater length of hospital stay, hospital readmission and death. A number of interventions have been used including giving diuretics which helps in decongestion and helps the heart pump blood more effectively. Sometimes these therapies are not effective and may even lead to worsening of renal function. In such cases , inotrope agents which increase the contractility of the heart have been used to help pump more blood to vital organs. There have been very few trials assessing the efficacy of these agents for improving kidney function .The investigators aim to assess the renal recovery with two such agents - dobutamine and milrinone in patients with cardiorenal syndrome who are coming with acute decompensated heart failure
Read the detailed description
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17billion or more. Chronic heart failure is one of the most life threatening cardiovascular disorder thought to affect nearly six million US population with annual death rate being 600,000. Cardiorenal syndrome although not completely understood in its full context - is a term coined for disorder of the heart and kidneys whereby acute or chronic dysfunction of one precipitates acute or chronic dysfunction of the other. Concomitant kidney failure amongst patients with acute decompensated heart failure is commonly observed . Direct and indirect effects of heart failure other than hemodynamic insult have been identified as primers for acute kidney injury and dysfunction. Patients with preexisting underlying renal disease are more likely to develop worsening renal failure in the setting of ADHF with venous congestion being the most important hemodynamic factor driving it. Worsening renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is associated with greater length of hospital stay, hospital readmission and death. The treatment of ADHF which includes the step up intravenous diuretic therapy in addition to optimizing baseline medicines is limited frequently by diuretic resistance and worsening creatinine level precluding use of Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blocking Agents (ARBs), and Spironolactone. Ultrafiltration/Aquapheresis still remains an option for treating non-responders to medical therapy. Inotropes have been known to produce a beneficial hemodynamic effect on heart and lead to better titration to oral regimen. Short term continous intravenous infusion of inotropic agents in patients with documented severe systolic dysfunction who present with significantly depressed cardiac output to maintain end organ perfusion has been shown to be beneficial as per the ACC/AHA guidelines 2013 for management of heart failure. The use of intravenous inotropes remains still a controversial topic in terms of its short lived and long term efficacy on renal recovery in acute decompensated heart failure. In view of the large proportion of patients admitted with acute decompensated heart failure and no real world studies comparing different inotropes to improve kidney function, the investigators aim to compare the efficacy of dobutamine and milrinone in improving kidney function and also their effect on length of stay, symptomatic improvement and medication optimisation
- The primary objective of the study is to objectively measure the response of dobutamine vs milrinone for renal recovery in patients with cardiorenal syndrome (>0.3mg/dl increase in creatinine from baseline) admitted for acute decompensated heart failure. These objective measures include change in serum creatinine, change in weight.
- The secondary objectives are to measure the length of hospitalization, readmission rates and unscheduled visits to the clinic or ER during 60 day follow up period. The investigators will also measure changes in symptoms which will be assessed using global and dyspnea visual analog scale every 24 hours until the patient is discharged .
- The secondary objectives also include to measure diuretic dose, medicine optimization including initiation of beta blocker / ace inhibitors before discharge, at 30 days and 60 days interval
- The investigators will subdivide the patients into ischemic versus non ischemic at the end of trial to see the response in both these categories of patients
- Conditions
- Cardiorenal Syndrome
- Being tested
- Milrinone, Dobutamine
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
Patients who meet the inclusion criteria for the study will receive milrinone and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight
DobutamineDrug
Patients who meet the inclusion criteria for the study will receive dobutamine and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight
| Study group | Role | What they receive |
|---|---|---|
| M-group | Active comparator | Will be given milrinone as an intravenous infusion at 0.2-0.6 mcg/kg/min for a maximum period of 72 hours and adjusted based on creatinine clearance measured by cockcroft-gault equation. It would be titrated based on hemodynamic response , urine output and at the discretion of the treating physician Receives: Drug: Milrinone |
| D-group | Active comparator | Will be given dobutamine as an intravenous infusion at a maximum rate of 20 mcg/kg/min depending on patient tolerance and would adjusted based on hemodynamic response, urine output and at the discretion of treating physician Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine measured in mg/dl(milligram/decilitre)
Measured: Serum Creatinine would be measured every 24 hours in mg/dl from the time of enrollment in the study and will be measured every 24 hours up to a maximum period of 14 days
Secondary outcomes (5)
Length of hospitalisation
Length of stay will start from the day patient is admitted up to a maximum of 30 days
Measured: Length of stay measured in days up to a maximum of 30 days
Readmission rate
Measured: Readmissions would be assessed for a period of 90 days
Global visual analog score
Measured: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days
Dyspnea visual analog score
Measured: Every 24 hours starting from the day of enrollment in the study up to a maximum period of 14 days
Urine output measured in milliliters in a 24 hour period
Urine output would be strictly monitored in millilitres /24 hours starting from the day of enrollment in the study till the patient is discharged from the hospital
Measured: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startMar 2016 (estimated)
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Could not enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiorenal SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Moskovits, Maimonides Medical Center
- Investigators
- Norbert Moskovits, MD, Principal investigator, Maimonides Medical CenterKaran Wats, MBBS, Principal investigator, Maimonides Medical CenterSyeda A Batul, MBBS, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644057
- Sponsor's protocol ID
- 2015-05-11-MMC
- Acronym
- DOMICAS
- Status last verified
- Mar 2018
- First submitted
- 29 Oct 2015
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008 Nov 4;52(19):1527-39. doi: 10.1016/j.jacc.2008.07.051.
PubMed 19007588Abraham WT, Adams KF, Fonarow GC, Costanzo MR, Berkowitz RL, LeJemtel TH, Cheng ML, Wynne J; ADHERE Scientific Advisory Committee and Investigators; ADHERE Study Group. In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medications: an analysis from the Acute Decompensated Heart Failure National Registry (ADHERE). J Am Coll Cardiol. 2005 Jul 5;46(1):57-64. doi: 10.1016/j.jacc.2005.03.051.
PubMed 15992636Cuffe MS, Califf RM, Adams KF Jr, Benza R, Bourge R, Colucci WS, Massie BM, O'Connor CM, Pina I, Quigg R, Silver MA, Gheorghiade M; Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1541-7. doi: 10.1001/jama.287.12.1541.
PubMed 11911756Elkayam U, Tasissa G, Binanay C, Stevenson LW, Gheorghiade M, Warnica JW, Young JB, Rayburn BK, Rogers JG, DeMarco T, Leier CV. Use and impact of inotropes and vasodilator therapy in hospitalized patients with severe heart failure. Am Heart J. 2007 Jan;153(1):98-104. doi: 10.1016/j.ahj.2006.09.005.
PubMed 17174645
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dobutamine Versus Milrinone for Renal Recovery in Patients With Cardiorenal Syndrome-A Prospective Cohort Study in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT02644057
- Acronym / sponsor ID
- DOMICAS / 2015-05-11-MMC
- Conditions
- Cardiorenal Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (estimated)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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.
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more. Chronic heart failure is one of the most life threatening cardiovascular disorder thought to affect nearly six million US population with 600,000 new cases every year. The heart is responsible for perfusion to all vital organs including kidneys and dysfunction in either affects both the vital organs. When dysfunction of heart leads to dysfunction of kidneys or vice versa it is referred to as cardio renal syndrome (CRS). The underlying pathophysiology for CRS has been poorly understood and considered multifactorial. Worsening renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is associated with greater length of hospital stay, hospital readmission and death. A number of interventions have been used including giving diuretics which helps in decongestion and helps the heart pump blood more effectively. Sometimes these therapies are not effective and may even lead to worsening of renal function. In such cases , inotrope agents which increase the contractility of the heart have been used to help pump more blood to vital organs. There have been very few trials assessing the efficacy of these agents for improving kidney function .The investigators aim to assess the renal recovery with two such agents - dobutamine and milrinone in patients with cardiorenal syndrome who are coming with acute decompensated heart failure
Detailed description
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17billion or more. Chronic heart failure is one of the most life threatening cardiovascular disorder thought to affect nearly six million US population with annual death rate being 600,000. Cardiorenal syndrome although not completely understood in its full context - is a term coined for disorder of the heart and kidneys whereby acute or chronic dysfunction of one precipitates acute or chronic dysfunction of the other. Concomitant kidney failure amongst patients with acute decompensated heart failure is commonly observed . Direct and indirect effects of heart failure other than hemodynamic insult have been identified as primers for acute kidney injury and dysfunction. Patients with preexisting underlying renal disease are more likely to develop worsening renal failure in the setting of ADHF with venous congestion being the most important hemodynamic factor driving it. Worsening renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is associated with greater length of hospital stay, hospital readmission and death. The treatment of ADHF which includes the step up intravenous diuretic therapy in addition to optimizing baseline medicines is limited frequently by diuretic resistance and worsening creatinine level precluding use of Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blocking Agents (ARBs), and Spironolactone. Ultrafiltration/Aquapheresis still remains an option for treating non-responders to medical therapy. Inotropes have been known to produce a beneficial hemodynamic effect on heart and lead to better titration to oral regimen. Short term continous intravenous infusion of inotropic agents in patients with documented severe systolic dysfunction who present with significantly depressed cardiac output to maintain end organ perfusion has been shown to be beneficial as per the ACC/AHA guidelines 2013 for management of heart failure. The use of intravenous inotropes remains still a controversial topic in terms of its short lived and long term efficacy on renal recovery in acute decompensated heart failure. In view of the large proportion of patients admitted with acute decompensated heart failure and no real world studies comparing different inotropes to improve kidney function, the investigators aim to compare the efficacy of dobutamine and milrinone in improving kidney function and also their effect on length of stay, symptomatic improvement and medication optimisation
- The primary objective of the study is to objectively measure the response of dobutamine vs milrinone for renal recovery in patients with cardiorenal syndrome (>0.3mg/dl increase in creatinine from baseline) admitted for acute decompensated heart failure. These objective measures include change in serum creatinine, change in weight.
- The secondary objectives are to measure the length of hospitalization, readmission rates and unscheduled visits to the clinic or ER during 60 day follow up period. The investigators will also measure changes in symptoms which will be assessed using global and dyspnea visual analog scale every 24 hours until the patient is discharged .
- The secondary objectives also include to measure diuretic dose, medicine optimization including initiation of beta blocker / ace inhibitors before discharge, at 30 days and 60 days interval
- The investigators will subdivide the patients into ischemic versus non ischemic at the end of trial to see the response in both these categories of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-group | Active comparator | Drug: MilrinoneWill be given milrinone as an intravenous infusion at 0.2-0.6 mcg/kg/min for a maximum period of 72 hours and adjusted based on creatinine clearance measured by cockcroft-gault equation. It would be titrated based on hemodynamic response , urine output and at the discretion of the treating physician |
| D-group | Active comparator | Drug: DobutamineWill be given dobutamine as an intravenous infusion at a maximum rate of 20 mcg/kg/min depending on patient tolerance and would adjusted based on hemodynamic response, urine output and at the discretion of treating physician |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Admitted to the hospital with a primary diagnosis of Decompensated Heart Failure
- Onset of cardio-renal syndrome (increasing creatinine>0.3mg/dl) after or before hospitalization. After hospitalization within 7 days of from the time of admission after receiving intravenous diuretics and heart failure medication optimization. Before hospitalization in the setting of escalating doses of outpatient loop diuretics and heart failure medication optimization
- Persistent volume overload- For patients with a pulmonary artery catheter, peristent volume overload will include :
- Pulmonary capillary wedge pressure >22mm Hg and one of the following clinical signs :2+ peripheral edema and/or pulmonary edema or pleural effusion on chest Xray. For patients without a pulmonary artery catheter- persistent volume overload will include atleast 2 of the following: 2+ peripheral edema , jugular venous pressure >10 mm Hg and pulmonary edema or pleural effusion on chest Xray
Key exclusion criteria (8 listed)
- Intravascular volume depletion
- Acute coronary syndrome within 4 weeks
- Indication for hemodialysis
- Systolic Blood pressure <90mm Hg or MAP<60mm Hg at the time of enrollment
- Alternate explanation for worsening renal function , such as obstructive nephropathy , contrast induced nephropathy , ATN
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 |
|---|---|---|
| MilrinonePatients who meet the inclusion criteria for the study will receive milrinone and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight | Drug | M-group |
| DobutaminePatients who meet the inclusion criteria for the study will receive dobutamine and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight | Drug | D-group |
Primary outcome
Serum creatinine measured in mg/dl(milligram/decilitre)
Time frame: Serum Creatinine would be measured every 24 hours in mg/dl from the time of enrollment in the study and will be measured every 24 hours up to a maximum period of 14 days
5 secondary outcomes
Length of hospitalisation
Time frame: Length of stay measured in days up to a maximum of 30 days
Readmission rate
Time frame: Readmissions would be assessed for a period of 90 days
Global visual analog score
Time frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days
Dyspnea visual analog score
Time frame: Every 24 hours starting from the day of enrollment in the study up to a maximum period of 14 days
Urine output measured in milliliters in a 24 hour period
Time frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Background: PubMed 19007588Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008 Nov 4;52(19):1527-39. doi: 10.1016/j.jacc.2008.07.051.
- Background: PubMed 15992636Abraham WT, Adams KF, Fonarow GC, Costanzo MR, Berkowitz RL, LeJemtel TH, Cheng ML, Wynne J; ADHERE Scientific Advisory Committee and Investigators; ADHERE Study Group. In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medications: an analysis from the Acute Decompensated Heart Failure National Registry (ADHERE). J Am Coll Cardiol. 2005 Jul 5;46(1):57-64. doi: 10.1016/j.jacc.2005.03.051.
- Background: PubMed 11911756Cuffe MS, Califf RM, Adams KF Jr, Benza R, Bourge R, Colucci WS, Massie BM, O'Connor CM, Pina I, Quigg R, Silver MA, Gheorghiade M; Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1541-7. doi: 10.1001/jama.287.12.1541.
- Background: PubMed 17174645Elkayam U, Tasissa G, Binanay C, Stevenson LW, Gheorghiade M, Warnica JW, Young JB, Rayburn BK, Rogers JG, DeMarco T, Leier CV. Use and impact of inotropes and vasodilator therapy in hospitalized patients with severe heart failure. Am Heart J. 2007 Jan;153(1):98-104. doi: 10.1016/j.ahj.2006.09.005.
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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.
Norbert Moskovits, MD principal investigator
Maimonides Medical Center
Karan Wats, MBBS principal investigator
Maimonides Medical Center
Syeda A Batul, MBBS principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milrinone and Dobutamine in people with Cardiorenal Syndrome, run by Maimonides Medical Center at 1 site in United States.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Aug 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine measured in mg/dl(milligram/decilitre) (time frame: Serum Creatinine would be measured every 24 hours in mg/dl from the time of enrollment in the study and will be measured every 24 hours up to a maximum period of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644057, which also lists 4 linked publications.
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 10 Aug 2018.