UMIN-CTR Clinical Trial

Public title

Fenoldopam improves urine output in oliguric critically surgical patients, Observational

Acronym

Fenoldopam improves urine output in oliguric critically surgical patients, Observational

Scientific Title

Fenoldopam improves urine output in oliguric critically surgical patients, Observational

Scientific Title:Acronym

Fenoldopam improves urine output in oliguric critically surgical patients, Observational

Region

North America

Condition

Intensive care unit

Classification by specialty

Medicine in general	Surgery in general	Anesthesiology
Intensive care medicine	Not applicable	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

: Fenoldopam is a short acting dopamine A1 receptor agonist which mediates vasodilation of the renal arteries thereby increasing renal blood flow, creatinine clearance, urinary flow and excretion of sodium. The objectives of this study were to determine whether low-dose fenoldopam or low-dose fenoldopam + a diuretic improve urine output in acute renal failure patients providing a positive effect preventing fluid accumulation and also verify the renoprotective effect of fenoldopam in ICU.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The objectives of this study were to determine whether low-dose fenoldopam or low-dose fenoldopam + a diuretic improve urine output in acute renal failure

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<

Age-upper limit

80

years-old

>

Gender

Male

Key inclusion criteria

Patient selection criteria were, those who do not have CKD and which urine output was <500 milliliters in the last 6hrs period and consequently fulfill the criteria for acute renal injury (AKI) by the 2004 RIFLE (Table Rifle Criteria)

Key exclusion criteria

Patient selection criteria were, those who do not have CKD and which urine output was <500 milliliters in the last 6hrs period and consequently fulfill the criteria for acute renal injury (AKI) by the 2004 RIFLE (Table Rifle Criteria).

Target sample size

126

Name of lead principal investigator

1st name
Middle name
Last name	Rafael Barrera

Organization

Northwell Health System

Division name

Intensive unit care

Zip code

Address

27005 76th Ave, Queens, NY 11040

TEL

+17184703000

Email

RBarrera@northwell.edu

Name of contact person

1st name
Middle name
Last name	Cagliani

Organization

Northwell

Division name

Intensive care unit

Zip code

Address

461 West, 150th St

TEL

+15165908262

Homepage URL

Email

jcagliani@northwell.edu

Institute

IRB

Institute

Department

Personal name

Organization

No funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Northwell health System

Date of disclosure of the study information

2019

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Of the 126 patients, who met inclusion criteria, 87 patients received fenoldopam (0.03mcg/kg/min) alone and 39 patients received fenoldopam plus a diuretic in the first 24 hours (Image 1). Fenoldopam alone, significantly increased mean urine output to 1376ml in 24 hours, from an assumed baseline mean of 1000ml/24h (P=0.005). (Image 3). Fenoldopam plus diuretic also demonstrated an increase in mean urine output (1525 ml) in the first 24 hours (P=0.02). (Image 4). There was no statistically significant difference when fenoldopam was compared to fenoldopam plus a diuretic (p= 0.5). There was also no significant change in creatinine clearance from baseline in either group Mann-Whitney test p value=0.88 and p value=0.7 (Image 5, 6, and table 2). In terms of fluid accumulation, there is no significant change adding diuretics p value=0.92. 59% of patients with fenoldopam and 53%with fenoldopam+diuretics progressed to Injury/Fail.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2015

Year

03

Month

03

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Observational

Registered date

2018

Year

11

Month

21

Day

Last modified on

2018

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039865