NCT04130347

Brief Summary

Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Status
completed

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

April 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

October 16, 2019

Last Update Submit

October 17, 2019

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of AKI

    Frequency of AKI as defined by KDIGO

    the first 24- 72 hours postop

Secondary Outcomes (4)

  • Mortality

    30, 60 and 360 days postoperatively

  • Major Adverse Kidney Events

    30, 60 and 360 days postoperatively

  • Fluid balance

    24-72h

  • Electrolyte disturbances

    24-72h

Study Arms (4)

Pancreatic resection

Liver resection

HIPEC surgery

Gynecological debulking surgery

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.

You may qualify if:

  • Any of the selected procedures.

You may not qualify if:

  • Patient has expressed his or her will to nor participate in any study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

Blood samples collected one year ahead of surgery and one year after surgery.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 17, 2019

Study Start

April 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share