Prevalence and Consequences of Hyperlactemia Following Pa... | NCT06589102

Studies
Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery

NCT06589102

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

491Actual

Phase

Not provided

Conditions

Pancreatic Cancer
Pancreatic Cyst
Chronic Pancreatitis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

May 9, 2023

First Submission Date that Met QC Criteria

Sep 5, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to investigate the role of lactate elevation.

The main aims are:

Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications
Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

491Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay	hospital stay following surgery	All patients are followed until they leave the hospital, but a maximum of six months

Secondary Outcomes

Measure	Description	Time Frame
General postoperative complications	Defined as Clavien-Dindo grade III-V	All patients are followed until they leave the hospital, but a maximum of six months
ICU care	Organ failure requiring ICU care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing pancreatic surgery 2016-2018

Exclusion Criteria:

Patients unable to undergo scheduled surgery
Missing data in the postoperative period

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients scheduled to undergo major pancreatic surgery in a tertiary university hospital during 2016-18

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Huddinge	Stockholm County	141 86	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D010181	Pancreatic Cyst
D050500	Pancreatitis, Chronic

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

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Browse Branches

Not provided