Acute Kidney InjuryGDT-AKINCT02396901
Goal Direct Therapy to Prevent Acute Kidney Injury
A study testing Goal Direct Therapy in people with Acute Kidney Injury, run by University of Sao Paulo.
Trial summary
This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Goal Direct Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2017
- 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
- Cardiac surgery with Cardiopulmonary Bypass (CPB); Age greater than 18 years; Chronic kidney disease stages 3 and 4 (GFR less than 60 mL/min and greater than 15 mL/min); Sign the informed consent form.
Who cannot join
- Chronic renal insufficiency (GFR less than 15 mL/min); Heart surgery without CPB; Aortic procedures; Heart transplant or congenital heart disease; Prior use of Intra-Aortic Balloon Pump; Decompensated heart failure; Participation in other research protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery
This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.
Read the detailed description
This is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the development of the Acute Kidney Injury in the postoperative period of cardiac surgery. Patients undergoing cardiac surgery at the Heart Institute (InCor) - Brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (GDT or standard).
- Conditions
- Acute Kidney Injury
- Being tested
- Goal Direct Therapy
- Keywords
- early goal direct therapy, preventive strategies, cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Direct TherapyOther
Goal Direct Therapy - in this group patients will receive the standard treatment according with institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| GDT group | Experimental | Patients randomized to the GDT Group will care from a protective strategy with the suspension of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) 48 hours before surgery and receive hydration with lactated Ringer's solution at the rate of 1 mL/kg/h in the night before the surgery until the surgical procedure and perioperative hemodynamic therapy. Receives: Other: Goal Direct Therapy |
| Control group | Placebo comparator | Patients randomized to the control group will be treated in accordance with the care in the institution's routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.
Measured: Within 48h after cardiac surgery
Secondary outcomes (1)
Serious clinical complications
Defined according to the guidelines of the Society of Thoracic Surgeons and include: stroke, need for invasive mechanical ventilation for more than 48 hours, mediastinitis, or deep infection of the surgical wound, mortality, need for reoperation.
Measured: For 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduesley Santana Santos, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396901
- Sponsor's protocol ID
- SDC 4163/14/143
- Acronym
- GDT-AKI
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liano F, Pascual J. Epidemiology of acute renal failure: a prospective, multicenter, community-based study. Madrid Acute Renal Failure Study Group. Kidney Int. 1996 Sep;50(3):811-8. doi: 10.1038/ki.1996.380.
PubMed 8872955Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1--coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S2-22. doi: 10.1016/j.athoracsur.2009.05.053.
PubMed 19559822Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203. doi: 10.7326/0003-4819-128-3-199802010-00005.
PubMed 9454527Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.
PubMed 19398670Conlon PJ, Stafford-Smith M, White WD, Newman MF, King S, Winn MP, Landolfo K. Acute renal failure following cardiac surgery. Nephrol Dial Transplant. 1999 May;14(5):1158-62. doi: 10.1093/ndt/14.5.1158.
PubMed 10344355Bahar I, Akgul A, Ozatik MA, Vural KM, Demirbag AE, Boran M, Tasdemir O. Acute renal failure following open heart surgery: risk factors and prognosis. Perfusion. 2005 Oct;20(6):317-22. doi: 10.1191/0267659105pf829oa.
PubMed 16363316Boldt J, Brenner T, Lang J, Kumle B, Isgro F. Kidney-specific proteins in elderly patients undergoing cardiac surgery with cardiopulmonary bypass. Anesth Analg. 2003 Dec;97(6):1582-1589. doi: 10.1213/01.ANE.0000090146.02929.2E.
PubMed 14633524Fleming I, Hecker M, Busse R. Intracellular alkalinization induced by bradykinin sustains activation of the constitutive nitric oxide synthase in endothelial cells. Circ Res. 1994 Jun;74(6):1220-6. doi: 10.1161/01.res.74.6.1220.
PubMed 7514511Burns KE, Chu MW, Novick RJ, Fox SA, Gallo K, Martin CM, Stitt LW, Heidenheim AP, Myers ML, Moist L. Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a randomized controlled trial. JAMA. 2005 Jul 20;294(3):342-50. doi: 10.1001/jama.294.3.342.
PubMed 16030279Fisher AR, Jones P, Barlow P, Kennington S, Saville S, Farrimond J, Yacoub M. The influence of mannitol on renal function during and after open-heart surgery. Perfusion. 1998 May;13(3):181-6. doi: 10.1177/026765919801300305.
PubMed 9638715Hynninen MS, Niemi TT, Poyhia R, Raininko EI, Salmenpera MT, Lepantalo MJ, Railo MJ, Tallgren MK. N-acetylcysteine for the prevention of kidney injury in abdominal aortic surgery: a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2006 Jun;102(6):1638-45. doi: 10.1213/01.ANE.0000219590.79796.66.
PubMed 16717300Benedetto U, Sciarretta S, Roscitano A, Fiorani B, Refice S, Angeloni E, Sinatra R. Preoperative Angiotensin-converting enzyme inhibitors and acute kidney injury after coronary artery bypass grafting. Ann Thorac Surg. 2008 Oct;86(4):1160-5. doi: 10.1016/j.athoracsur.2008.06.018.
PubMed 18805152Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.
PubMed 17699187Bakris GL, Weir MR. Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine: is this a cause for concern? Arch Intern Med. 2000 Mar 13;160(5):685-93. doi: 10.1001/archinte.160.5.685.
PubMed 10724055Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol. 2005 Jan;16(1):162-8. doi: 10.1681/ASN.2004040331. Epub 2004 Nov 24.
PubMed 15563569
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02396901
- Acronym / sponsor ID
- GDT-AKI / SDC 4163/14/143
- Conditions
- Acute Kidney Injury
- Keywords
- early goal direct therapy, preventive strategies, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 24 Mar 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.
This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.
Detailed description
This is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the development of the Acute Kidney Injury in the postoperative period of cardiac surgery. Patients undergoing cardiac surgery at the Heart Institute (InCor) - Brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (GDT or standard).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDT group | Experimental | Other: Goal Direct TherapyPatients randomized to the GDT Group will care from a protective strategy with the suspension of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) 48 hours before surgery and receive hydration with lactated Ringer's solution at the rate of 1 mL/kg/h in the night before the surgery until the surgical procedure and perioperative hemodynamic therapy. |
| Control group | Placebo comparator | –Patients randomized to the control group will be treated in accordance with the care in the institution's routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery with Cardiopulmonary Bypass (CPB); Age greater than 18 years; Chronic kidney disease stages 3 and 4 (GFR less than 60 mL/min and greater than 15 mL/min); Sign the informed consent form.
Key exclusion criteria (1 listed)
- Chronic renal insufficiency (GFR less than 15 mL/min); Heart surgery without CPB; Aortic procedures; Heart transplant or congenital heart disease; Prior use of Intra-Aortic Balloon Pump; Decompensated heart failure; Participation in other research protocol.
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 |
|---|---|---|
| Goal Direct TherapyGoal Direct Therapy - in this group patients will receive the standard treatment according with institutional protocol. | Other | GDT group |
Primary outcome
Acute Kidney Injury
Time frame: Within 48h after cardiac surgery
Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.
1 secondary outcome
Serious clinical complications
Time frame: For 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Background: PubMed 8872955Liano F, Pascual J. Epidemiology of acute renal failure: a prospective, multicenter, community-based study. Madrid Acute Renal Failure Study Group. Kidney Int. 1996 Sep;50(3):811-8. doi: 10.1038/ki.1996.380.
- Background: PubMed 19559822Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1--coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S2-22. doi: 10.1016/j.athoracsur.2009.05.053.
- Results publication: PubMed 9454527Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203. doi: 10.7326/0003-4819-128-3-199802010-00005.
- Results publication: PubMed 19398670Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.
- Results publication: PubMed 10344355Conlon PJ, Stafford-Smith M, White WD, Newman MF, King S, Winn MP, Landolfo K. Acute renal failure following cardiac surgery. Nephrol Dial Transplant. 1999 May;14(5):1158-62. doi: 10.1093/ndt/14.5.1158.
- Results publication: PubMed 16363316Bahar I, Akgul A, Ozatik MA, Vural KM, Demirbag AE, Boran M, Tasdemir O. Acute renal failure following open heart surgery: risk factors and prognosis. Perfusion. 2005 Oct;20(6):317-22. doi: 10.1191/0267659105pf829oa.
- Results publication: PubMed 14633524Boldt J, Brenner T, Lang J, Kumle B, Isgro F. Kidney-specific proteins in elderly patients undergoing cardiac surgery with cardiopulmonary bypass. Anesth Analg. 2003 Dec;97(6):1582-1589. doi: 10.1213/01.ANE.0000090146.02929.2E.
- Results publication: PubMed 7514511Fleming I, Hecker M, Busse R. Intracellular alkalinization induced by bradykinin sustains activation of the constitutive nitric oxide synthase in endothelial cells. Circ Res. 1994 Jun;74(6):1220-6. doi: 10.1161/01.res.74.6.1220.
- Results publication: PubMed 16030279Burns KE, Chu MW, Novick RJ, Fox SA, Gallo K, Martin CM, Stitt LW, Heidenheim AP, Myers ML, Moist L. Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a randomized controlled trial. JAMA. 2005 Jul 20;294(3):342-50. doi: 10.1001/jama.294.3.342.
- Results publication: PubMed 9638715Fisher AR, Jones P, Barlow P, Kennington S, Saville S, Farrimond J, Yacoub M. The influence of mannitol on renal function during and after open-heart surgery. Perfusion. 1998 May;13(3):181-6. doi: 10.1177/026765919801300305.
- Results publication: PubMed 16717300Hynninen MS, Niemi TT, Poyhia R, Raininko EI, Salmenpera MT, Lepantalo MJ, Railo MJ, Tallgren MK. N-acetylcysteine for the prevention of kidney injury in abdominal aortic surgery: a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2006 Jun;102(6):1638-45. doi: 10.1213/01.ANE.0000219590.79796.66.
- Results publication: PubMed 18805152Benedetto U, Sciarretta S, Roscitano A, Fiorani B, Refice S, Angeloni E, Sinatra R. Preoperative Angiotensin-converting enzyme inhibitors and acute kidney injury after coronary artery bypass grafting. Ann Thorac Surg. 2008 Oct;86(4):1160-5. doi: 10.1016/j.athoracsur.2008.06.018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Direct Therapy in people with Acute Kidney Injury, run by University of Sao Paulo.
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 1 inclusion and 1 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Eduesley Santana-Santos, RN, Ph.D (+551126615434, eduesley@oi.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: Within 48h after cardiac surgery). 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 NCT02396901, which also lists 16 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 24 Mar 2015.