NCT00110201

Brief Summary

The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure. The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2005

First QC Date

May 4, 2005

Last Update Submit

June 23, 2005

Conditions

Keywords

Acute renal failureNesiritideCardiovascular surgery

Outcome Measures

Primary Outcomes (1)

  • Need for dialysis and/or mortality

Secondary Outcomes (2)

  • Rise in serum creatinine

  • blood urea nitrogen

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Undergoing thoracic aortic aneurysm surgery
  • Impaired renal function

You may not qualify if:

  • Prior history of allergy/adverse reaction to Nesiritide
  • History of any organ transplant
  • Preoperative intra-aortic balloon pump (IABP)
  • Decompensated congestive heart failure (CHF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (4)

  • Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

  • Dass B, Shimada M, Kambhampati G, Ejaz NI, Arif AA, Ejaz AA. Fluid balance as an early indicator of acute kidney injury in CV surgery. Clin Nephrol. 2012 Jun;77(6):438-44. doi: 10.5414/cn107278.

  • Ejaz AA, Beaver TM, Shimada M, Sood P, Lingegowda V, Schold JD, Kim T, Johnson RJ. Uric acid: a novel risk factor for acute kidney injury in high-risk cardiac surgery patients? Am J Nephrol. 2009;30(5):425-9. doi: 10.1159/000238824. Epub 2009 Sep 11.

  • Ejaz AA, Martin TD, Johnson RJ, Winterstein AG, Klodell CT, Hess PJ Jr, Ali AK, Whidden EM, Staples NL, Alexander JA, House-Fancher MA, Beaver TM. Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery. J Thorac Cardiovasc Surg. 2009 Oct;138(4):959-64. doi: 10.1016/j.jtcvs.2009.05.014. Epub 2009 Jul 3.

MeSH Terms

Conditions

Cardiovascular DiseasesAcute Kidney InjuryDeath

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Central Study Contacts

R Allan Finlay, RN

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

May 4, 2005

First Posted

May 5, 2005

Study Start

March 1, 2005

Study Completion

December 1, 2007

Last Updated

June 24, 2005

Record last verified: 2005-05

Locations