NCT01882218

Brief Summary

The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

June 17, 2013

Last Update Submit

May 2, 2017

Conditions

Hepatic Cancer

Keywords

Liver cancer

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    Six months

Secondary Outcomes (1)

  • Cytokine levels

    Six months

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Standard liver surgery and post-operative treatment

Drug: Standard Treatment

Galactose

EXPERIMENTAL

Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.

Drug: Galactose

Interventions

GalactoseDRUG

After surgery, galactose will be dripped into the belly for up to 24 hours after surgery

Galactose
Standard TreatmentDRUG

Standard liver surgery.

Standard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer
  • Scheduled for liver resection
  • to 75

You may not qualify if:

  • Chronic renal failure
  • Cirrhosis
  • Congestive heart failure
  • Requiring portal venous embolization prior to resection
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Galactose

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Jason Smith, MD

    U Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 20, 2013

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)