Alfred Hospital
Melbourne, Victoria, 3004, Australia
NCT Number: NCT04978285
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Melbourne, Victoria, 3004, Australia
The consequences of postoperative anemia remain unclear. Postoperative anaemia is more likely if there is pre-existing anemia, but also increased perioperative blood loss, frequent blood sampling, excess IV fluids (leading to hemodilution), sepsis, and inadequate nutritional intake after surgery. A nadir in Hb concentration is most often observed within the first 3-4 days after surgery. Postoperative anemia is believed to have deleterious effects on patient outcomes, including prolonged hospital stay, increased postoperative complications, and perhaps poor survival, but there is very little data to support this belief.
A recent consensus statement suggested that all patients recovering from major surgery (defined as blood loss > 500 ml or lasting > 2 h) and either had preoperative anemia or moderate-to-severe blood loss during surgery must be screened for anemia after surgery. Furthermore, this consensus group recommended that patients recovering from uncomplicated major surgery should have their Hb concentration measured for at least 3 days after surgery to detect anemia. As outlined above, this is problematic if there is fluid retention.
The role of IV iron for the treatment of postoperative anemia is unclear, with the most recent systematic review concluding that neither oral nor IV iron had a significant effect on patient quality of life or functional outcomes following surgery. A diagnosis of iron deficiency is very difficult in the postoperative period because the acute phase inflammatory response results in spuriously elevated ferritin levels, and several studies have demonstrated oral iron therapy is ineffective in this setting.
The investigators propose a study to investigate the incidence, extent, and outcomes of patients with anemia after major surgery, including an assessment of the amount of IV fluids administered in the immediate perioperative period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Depends on Day 3 Hb result
Other names: Observational
Time frame: 90 days after surgery
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.
Time frame: 1 year
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
CDC criteria
Time frame: 30 days
The presence of new and/or progressive pulmonary infiltrates on chest radiograph plus two or more of the following:
i. Fever ≥ 38.5°C or postoperative hypothermia <36°C ii. Leucocytosis ≥ 12,000 WBC/mm3 or leucopenia < 4,000 WBC/mm3 iii. Purulent sputum and/or iv. New onset or worsening cough or dyspnea.
Time frame: 30 days
A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- an extra luminal compartments.
Time frame: 30 days
According to The Kidney Disease: Improving Global Outcomes (KDIGO) group criteria, but not urine output - for Stage 2 or worse AKI defined as at least 2-fold increase in creatinine, or estimated GFR decrease >50%
Time frame: 30 days
Time frame: 30 days
Total days - additive, including initial ICU admission and readmission times up to Day 30
Time frame: 30 days
Total -additive, from the start (date, time) of surgery until actual hospital discharge , plus readmission(s) up to Day 30
Time frame: Postoperative Days 3 and 30
QoR-15 scale score
Time frame: At 3, 6 and 12 months.
Bayside Health
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02075970
Anemia, Anemia, Neonatal
Iowa City, Iowa, United States
View Trial DetailsNCT05750654
Anemia, Hematologic Diseases
Houston, Texas, United States
View Trial DetailsNCT03369210
Anemia, Hematologic Diseases
Aachen, Germany
View Trial DetailsNCT01572506
Anemia, Hematologic Diseases
Baltimore, Maryland, United States
View Trial Details