NCT01860001

Brief Summary

The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

May 20, 2013

Last Update Submit

May 20, 2013

Conditions

Metabolic Acidosis

Keywords

cancermetabolic acidosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery

    31/08/13

Secondary Outcomes (1)

  • Incidence of metabolic acidosis, defined by base deficit . 2 mEq/L (Henderson-Hasselback) within one hour of completion of surgery.

    31/08/13

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital patients seen in pre-operative assessment clinic

You may qualify if:

  • Patients who have undergone major cancer surgery
  • Patients who have an arterial line in place
  • Patients who have a urinary catheter in place
  • Patients who will be admitted to intensive care following surgery
  • Adults \>18 years
  • Adults who are capable of reading and understanding English

You may not qualify if:

  • Patient refusal
  • Patients without an arterial line or urinary catheter in place
  • Patients receiving glucose / sliding scale insulin for management of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, England, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

AcidosisNeoplasms

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Timothy Wigmore

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Wigmore, BM BCH

CONTACT

02073528181timothy.wigmore@rmh.nhs.ukl

Shaman Jhanji, MB ChB PhD

CONTACT

020780846323shama.jhanji@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

GB(1)