Association of Postoperative Anaemia With Patient-centred Outcomes

NCT04978285 | Completed

• 1 other identifier: 544/12
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim - To investigate the relationship between postoperative anaemia and patient-centred outcomes after major abdominal surgery. Secondary aim - To determine whether a more liberal perioperative IV fluid strategy increases the risk of postoperative anaemia (haemodilution). Hypothesis: Adults with anaemia in the immediate postoperative period following major abdominal surgery have a poorer quality of recovery and higher risk of complications, leading to poor disability-free survival when compared with patients without postoperative anaemia.

Conditions

Anemia After Surgery

Keywords

anemia; complications; hemoglobin; iron; patient-centered outcome; surgery

Outcome Measures

Primary Outcomes (1)

• Persistent disability or death by 90 days

  Defined as a World Health Organization Disability Assessment Schedule 2.0 (WHODAS) score of at least 24 points (on the 48-point scale) at both 30 and 90 days postoperatively, reflecting a disability level of at least 25% and being the threshold point between "disabled" and "not disabled" as per WHO guidelines. Disability was assessed by the participant, but if unable then we used the proxy's report.

  90 days after surgery

Secondary Outcomes (12)

• Death: all-cause mortality at 90 days, then up to 12 months after surgery

  1 year

• A composite (pooled) and individual septic complications: sepsis, surgical site infection, anastomotic leak, and pneumonia

  30 days

• Sepsis: using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria

  30 days

• Surgical site infection

  30 days

• Pneumonia

  30 days

Study Arms (2)

Postoperative anemia

All patients enrolled in the RELIEF trial in which a postoperative Day 1-3 hemoglobin concentration was measured. Anaemia will be defined according to the World Health Organisation definition (males Hb \<130 g/L, and female Hb \<120 g/L).

Other: Anemia

No postoperative anemia

All patients enrolled in the RELIEF trial in which a postoperative Day 1-3 hemoglobin concentration was measured. No anaemia will be defined according to the World Health Organisation definition (males Hb ≥130 g/L, and females Hb ≥120 g/L).

Other: Anemia

Interventions

Anemia OTHER

Depends on Day 3 Hb result

Also known as: Observational

No postoperative anemia; Postoperative anemia

Eligibility Criteria

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

Study Population

Adult, elective major abdominal surgery

You may qualify if:

• Adults (≥18 years) undergoing elective major surgery and providing informed consent
• All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days
• At increased risk of postoperative complications, as defined by any of the following criteria:
• age ≥70 years
• known or documented history of coronary artery disease
• known or documented history of heart failure
• diabetes currently treated with an oral hypoglycemic agent and/or insulin
• preoperative serum creatinine \>200 micromol/L (\>2.8 mg/dl)
• morbid obesity (BMI ≥35 kg/m2)
• preoperative serum albumin \<30 g/L
• anaerobic threshold (if done) \<12 mL/kg/min
• or two or more of the following risk factors:
• ASA 3 or 4
• chronic respiratory disease
• obesity (BMI 30-35 kg/m2)

You may not qualify if:

• Urgent or time-critical surgery
• ASA physical status 5 - such patients are not expected to survive with or without surgery, and their underlying illness is expected to have an overwhelming effect on outcome (irrespective of fluid therapy)
• Chronic renal failure requiring dialysis
• Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
• Liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
• Minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethral resection of the prostate, inguinal hernia repair, splenectomy, closure of colostomy - each of these are typically "minor" surgery with minimal IV fluid requirements, generally low rates of complications and mostly very good survival.

Sponsors & Collaborators

• Bayside Health: lead
• Monash University: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

• Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.

  PMID: 29742967 BACKGROUND

• Myles PS, Richards T, Klein A, Wood EM, Wallace S, Shulman MA, Martin C, Bellomo R, Corcoran TB, Peyton PJ, Story DA, Leslie K, Forbes A; RELIEF Trial Investigators. Postoperative anaemia and patient-centred outcomes after major abdominal surgery: a retrospective cohort study. Br J Anaesth. 2022 Sep;129(3):346-354. doi: 10.1016/j.bja.2022.06.014. Epub 2022 Jul 15.

  PMID: 35843746 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 27, 2021
• Study Start: July 16, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: July 13, 2022

Record last verified: 2021-07

Locations

AU (1)