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Acute Kidney InjuryRFRNCT03092947

Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery

An observational study of Acute Kidney Injury, run by University of Giessen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Kidney Injury
How many people
110 participants
Where
No sites listed yet
Study dates
1 Nov 2014to 28 Feb 2016
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adult patients undergoing elective cardiac surgery

Who may be able to join

  • Subjects older than 18 years
  • Subjects undergoing elective cardiac surgery
  • Subjects who signed informed consent forms

Who cannot join

  • Pregnancy
  • Chronic kidney disease ≥ stage III
  • Solitary kidney
  • Diabetes mellitus type 1
  • Recent cardiac arrest
  • Liver failure or cirrhosis
Show all 26Show fewer
  • Total parenteral nutrition
  • Hemoglobin <11 g/dl
  • Sepsis
  • History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
  • Transplant donor or recipient
  • Active autoimmune disease with renal involvement
  • Rhabdomyolysis
  • Prostate hypertrophy with International Prostate Symptom Score ≥20
  • Neoplasm
  • Withdrawal criteria:
  • All patients included in the study were to be followed up until the scheduled end of the study. Data collection could be terminated prior to the scheduled time only under the following conditions:
  • General criteria
  • A patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent),
  • The investigator may withdraw a patient from the participation in the study at any time for the following reasons:
  • a severe protocol violation,
  • the development of incidents/near-incidents/other severe clinical complications related to the study protocol
  • Criteria related to the study
  • Subjects who could not stop taking angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers a minimum of 48 hours before the protein load.
  • Subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load.
  • Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.

About this study

Official title: Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity. We hypothesized that preoperative RFR would predict postoperative AKI.

Read the detailed description

Acute kidney injury (AKI) is a frequent complication in patients undergoing cardiac surgery with an estimated prevalence of 36%. However, clinicians have limited tools to preoperatively identify patients at risk for AKI and/or progression to chronic kidney disease, particularly in patients with normal resting glomerular filtration rate (rGFR). Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase GFR from baseline in response to stimuli (e.g., protein load). We hypothesized that the presence or absence of RFR could separate patients at risk for developing AKI from patients with better-preserved renal function and a more favorable short- and long-term prognosis despite identical rGFR. The aim of this study is to examine whether preoperative assessment of RFR is able to predict risk for AKI after cardiac surgery.

Being tested
No intervention
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.

  • No interventionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The predictive value of RFR for AKI in patients undergoing elective cardiac surgery

    Measured: 1 day before cardiac surgery

Secondary outcomes (2)

  1. Whether the occurrence of AKI (as defined by Kidney Disease Improving Global Outcomes criteria) impacts RFR three months after surgery in patients without ongoing reduced function defined by resting GFR

    Measured: 3 months after cardiac surgery

  2. Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR

    Measured: 3 months after cardiac surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start1 Nov 2014
  3. Primary completion31 Oct 2015
  4. Study completion28 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092947
Sponsor's protocol ID
n63/14
Acronym
RFR
Status last verified
Mar 2017
First submitted
21 Mar 2017
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haase M, Kellum JA, Ronco C. Subclinical AKI--an emerging syndrome with important consequences. Nat Rev Nephrol. 2012 Dec;8(12):735-9. doi: 10.1038/nrneph.2012.197. Epub 2012 Sep 25.

    PubMed 23007617

  • Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26. doi: 10.5414/CN108497.

    PubMed 27285313

  • Ronco C, Chawla LS. Glomerular and Tubular Kidney Stress Test: New Tools for a Deeper Evaluation of Kidney Function. Nephron. 2016;134(3):191-194. doi: 10.1159/000449235. Epub 2016 Aug 30.

    PubMed 27577054

  • Husain-Syed F, Emlet DR, Wilhelm J, Danesi TH, Ferrari F, Bezerra P, Lopez-Giacoman S, Villa G, Tello K, Birk HW, Seeger W, Giavarina D, Salvador L, Fuhrman DY, Kellum JA, Ronco C; IRRIV-AKI Study Group. Effects of preoperative high-oral protein loading on short- and long-term renal outcomes following cardiac surgery: a cohort study. J Transl Med. 2022 May 10;20(1):204. doi: 10.1186/s12967-022-03410-x.

    PubMed 35538495

  • Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.

    PubMed 30053231

  • Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.

    PubMed 29382510

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury, run by University of Giessen.

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 3 inclusion and 26 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: finished, as of the sponsor's last update on 29 Mar 2017. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The predictive value of RFR for AKI in patients undergoing elective cardiac surgery (time frame: 1 day before 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 NCT03092947, which also lists 6 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 29 Mar 2017.

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