Vascular Changes During Colorectal Surgery

NCT02136277 | Unknown

• 1 other identifier: 13115
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether increases in the blood flow from the heart (the cardiac output), induced by the administration of intravenous fluids, lead to an increase in the blood flow to the vital organs, in patients undergoing bowel surgery. This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the research fellow (medical doctor) undertaking this study, who will check their suitability to participate in the study and who will obtain informed consent. The second phase is the study itself which will take place whilst volunteers are having their bowel operation. They will attend theatre in the normal way, but once they have been anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in bowel surgery to help assess how much intravenous fluid to administer to a patient by measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the blood flow to these organs. A small sample of blood will be taken from the earlobe to allow us to measure a chemical in the blood called lactate. After this, intravenous fluid will be administered in order to increase the amount of blood pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate amount of fluid has been given, a second ultrasound scan will be performed to measure whether blood flow to the abdominal organs has also increased. A further blood sample will be taken from your earlobe to measure any change in lactate level. At the completion of the operation, a third ultrasound scan will be performed and another sample of blood taken from the earlobe, to help assess blood flow to the organs.

Conditions

Patients Undergoing Open Resection of Colorectal Tumours

Keywords

colorectal surgery; cardiac output

Outcome Measures

Primary Outcomes (1)

• Changes in microvascular blood flow during colorectal surgery

  Immediately following optimisation of cardiac output

Study Arms (1)

Colorectal patients

Subjects undergoing colorectal surgery

Drug: Hartmann's solution

Interventions

Hartmann's solution DRUG

Administered in 250ml boluses, until cardiac output has been optimised.

Also known as: Compound sodium lactate solution, Ringer's lactate solution, Lactated Ringer's solution

Colorectal patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancers, scheduled to undergo open resectional surgery.

You may qualify if:

• Aged 18 - 80 years
• Confirmed colorectal cancer
• Offered surgery by Derbyshire colorectal multidisciplinary team
• No metastatic disease
• Able to consent in English by themselves

You may not qualify if:

• Metastatic disease
• Oesophageal varices
• Patients with recent acute coronary syndrome (symptoms involving the heart) or unstable ischaemic cardiac disease (reduced blood supply to the heart);
• Patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs);
• Pregnant or breast-feeding women;
• Known sensitivity to Sonovue;
• Prolonged QT syndrome

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

RECRUITING

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• John P Williams, PhD

  University of Nottingham

  STUDY CHAIR

Central Study Contacts

John P Williams, PhD

CONTACT

01332 724641; john.williams7@nhs.net

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research fellow in anaesthesia

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

GB (1)