Incidence of Postoperative Ketosis and Metabolic Acidosis (POKACID)

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Acidosis

Detailed Description

Metabolic acidosis is a frequent occurrence following major surgery. Monitoring acid base disturbances and in particular diagnosing the aetiology of the acidosis are important parts of assessing a patient's cardiovascular status following surgery. The presence of a metabolic acidosis is frequently attributed to anaerobic metabolism leading to the generation of lactic acid due to hypovolaemia and poor tissue perfusion. This commonly results in clinicians treating postoperative patients with a metabolic acidosis by administering intravenous fluids containing 0.9% saline or Hartmann's solution (compound sodium lactate). If the cause of the metabolic acidosis is not hypovolaemia, treatment with intravenous fluids may actually exacerbate the acidosis by causing hyperchloraemia. An often overlooked cause of metabolic acidosis after surgery is starvation leading to ketoacidosis. All patients are starved for a minimum of six hours prior to general anaesthesia due to the potential risk of aspiration of gastric contents into the bronchial tree. Many patients are in fact fasted for much longer periods than this. There is, however, little data describing the incidence of ketoacidosis following surgery. In addition, there may be other causes of acidosis after surgery which often overlooked but can be determined using equations and mathematical models. The aim of this study is to define the incidence and nature of acidosis after major cancer surgery using using equations to directly determine acids. This study will also aim to compare the ability of commonly used 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Timothy Wigmore, BM BCH; Phone Number: 1968 02073528181; Email: timothy.wigmore@rmh.nhs.ukl
• Study Contact Backup: Name: Shaman Jhanji, MB ChB PhD; Phone Number: 020780846323; Email: shama.jhanji@rmh.nhs.uk

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, SW3 6JJ
      • Recruiting
      • Royal Marsden NHS Foundation Trust
      • Contact: Timothy Wigmore; Phone Number: 1968 02073528171; Email: timothy.wigmore@rmh.nhs.uk
      • Contact: Shaman Jhanji; Phone Number: 02073528171; Email: shaman.jhanji@rmh.nhs.uk
      • Principal Investigator: Timothy Wigmore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital patients seen in pre-operative assessment clinic

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery	31/08/13

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of metabolic acidosis, defined by base deficit . 2 mEq/L (Henderson-Hasselback) within one hour of completion of surgery.	31/08/13

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Timothy Wigmore, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: cancer; metabolic acidosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: CCR3828