Effects of Aminophylline on Renal Function and Urine Volume of AKI Patient

NCT02983422 | Unknown Early Phase 1 DMC

• 1 other identifier: SSH-ICU-017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of aminophylline on serum creatinine and urine volume of AKI Patient.Half of participants will receive aminophylline and furosemide in combination,while the other half will receive only furosemide.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

• serum creatinine

  Change from serum creatinine at 2 weeks

• urine volume

  Change from urine volume at 2 weeks

• Serum cystatin-C

  Change from Serum cystatin-C at 2 weeks

• Urine β_2-microglobulin

  Change from Urine β_2-microglobulin at 2 weeks

Secondary Outcomes (3)

• dose of norepinephrine

  Change from dose of norepinephrine at 2 weeks

• blood pressure

  Change from baseline systolic blood pressure at 2 weeks

• central venous pressure

  Change from central venous pressure at 2 weeks

Study Arms (2)

Group aminophylline

ACTIVE COMPARATOR

To increase the dose of frusemide until 15mg/h with Syringe pumps. If the urine doesn't reach 1ml/kg/h,then combined with Aminophylline(loading dose of 5mg/kg，and maintenance dose of 0.5mg/kg)

Drug: aminophylline; Drug: frusemide

Group frusemide

PLACEBO COMPARATOR

Use frusemide with Syringe pumps,maximum dose to 15mg/h，with placebo bolus followed by IV infusions of normal saline (0.9%) every hour (matched by volume and appearance to the treatment group)

Drug: frusemide; Drug: normal saline

Interventions

aminophylline DRUG

To increase the dose of frusemide until 15mg/h with Syringe pumps. If the urine doesn't reach 1ml/kg/h,then combined with Aminophylline(loading dose of 5mg/kg，and maintenance dose of 0.5mg/kg)

Group aminophylline

frusemide DRUG

Use frusemide with Syringe pumps,maximum dose to 15mg/h

Group aminophylline; Group frusemide

normal saline DRUG

Placebo bolus followed by IV infusions of normal saline (0.9%) every hour (matched by volume and appearance to the treatment group)

Group frusemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute injury (AKI) with no lack of circulating volume (central venous pressure \>8cmH2O)

You may not qualify if:

• Patients with chronic kidney disease
• Patients with acute renal injury caused by insufficient circulating volume
• Patients who do not cooperate with the use of the drug therapy
• Patients who do not cooperate with the relevant examination

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Related Publications (4)

• Parker MR, Willatts SM. A pilot study to investigate the effects of an infusion of aminophylline on renal function following major abdominal surgery. Anaesthesia. 2001 Jul;56(7):670-5. doi: 10.1046/j.1365-2044.2001.01374.x.

  PMID: 11437769 BACKGROUND

• Lynch BA, Gal P, Ransom JL, Carlos RQ, Dimaguila MA, Smith MS, Wimmer JE Jr, Imm MD. Low-dose aminophylline for the treatment of neonatal non-oliguric renal failure-case series and review of the literature. J Pediatr Pharmacol Ther. 2008 Apr;13(2):80-7. doi: 10.5863/1551-6776-13.2.80.

  PMID: 23055869 BACKGROUND

• Yang GZ, Xue FS, Liu GP, Sun C. Use of Aminophylline to Prevent Acute Kidney Injury After Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2016 Aug;17(8):814. doi: 10.1097/PCC.0000000000000838. No abstract available.

  PMID: 27500627 BACKGROUND

• Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, Bart BA, Bull DA, Stehlik J, LeWinter MM, Konstam MA, Huggins GS, Rouleau JL, O'Meara E, Tang WH, Starling RC, Butler J, Deswal A, Felker GM, O'Connor CM, Bonita RE, Margulies KB, Cappola TP, Ofili EO, Mann DL, Davila-Roman VG, McNulty SE, Borlaug BA, Velazquez EJ, Lee KL, Shah MR, Hernandez AF, Braunwald E, Redfield MM; NHLBI Heart Failure Clinical Research Network. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial. JAMA. 2013 Dec 18;310(23):2533-43. doi: 10.1001/jama.2013.282190.

  PMID: 24247300 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Aminophylline; Furosemide; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Sulfones; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Xuemin Wang, PhD

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yanding Gao

CONTACT

13917337835; masa_oreo@yeah.net

Haiyan Wang

CONTACT

18930174845; mgul@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 6, 2016

Record last verified: 2016-12