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Evaluation of two strategies for volume replacement in patients undergoing abdominal surgery

Comparison between two strategies for perioperative volume replacement in abdominal surgeries: continuous infusion versus bolus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6ybk8kr
Enrollment
Unknown
Registered
2021-05-04
Start date
2012-05-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive system diseases, Digestive System Surgical Procedures, Elective Surgical Procedures, Anesthesia, General, Postoperative Complications.

Interventions

The 85 patients who underwent open abdominal surgeries with a minimum duration of 120 minutes in the supine position under general anesthesia were divided into two groups. The control group had 42 pat

Sponsors

Faculdade de Medicina de Botucatu UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu UNESP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ASA I, II or III patients; Adults; Both sexes; Undergoing open abdominal surgeries; Minimum surgical duration of 120 minutes; Supine position during surgery; Undergoing general anesthesia

Exclusion criteria

Exclusion criteria: BMI greater than 35kg.m2; Gestation, chronic obstructive pulmonary disease or bronchial infection; Coagulopathies; Changes in preoperative renal function; Sepsis or SIRS; Hepatic insufficiency; Emergency or emergency surgeries; Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 Reduced hospital stay in days, from immediate postoperative to hospital discharge or death during hospitalization;Outcome found 1 There was no statistically significant difference between the control and bolus duration of hospitalization (p = 0.58);Expected outcome 2 Lower mortality in the first 30 days after surgery;Observed outcome 2 There was no statistically significant difference between the control and bolus groups regarding mortality in the first thirty days after surgery (p = 0.43);Expected outcome 3 Less time in days for the return of gastrointestinal tract function evaluated by first postoperative evacuation and reintroduction of diet.;Observed outcome 3 There was no statistically significant difference between the control and bolus groups regarding the return of gastrointestinal tract function, assessed by first postoperative evacuation (p = 0.95) and diet reintroduction (p = 0.22);Expected outcome 4 Reduced incidence of postoperative complications in the bolus group measured by the number of patients who presented at least 1 of the following postoperative complications (pneumonia, unprogrammed orotracheal intubation, surgical wound infection, wall dehiscence, anastomosis dehiscence, deep venous thrombosis, pulmonary thromboembolism, cardiac arrhythmia, acute renal injury, need for dialysis, sepsis / septic shock, hemorrhage, death for up to thirty days);Observed outcome 4 Reduced incidence of postoperative complications in the bolus group (14%) than in the control group (45%), p = 0.003.

Secondary

MeasureTime frame
Secondary endpoint observed 2 Fewer postoperative pulmonary complications in the bolus group, being determined by the presence of pneumonia, unprogrammed orotracheal intubation, pulmonary thromboembolism and acute respiratory failure (p = 0.003).;Expected secondary endpoint 1 Reduced incidence of acute postoperative renal injury in the bolus group, as measured by serum creatinine, Ngal, and cystatin C levels measured on the preoperative, second and fifth postoperative days operative.;Expected secondary outcome 2 Fewer postoperative pulmonary complications in the bolus group, being determined by the presence of pneumonia, unprogrammed orotracheal intubation, pulmonary thromboembolism and acute respiratory failure.;Secondary outcome observed 1 There was no statistically significant difference between the control group and the bolus group for serum creatinine (p = 0.95), Ngal (p = 0.29), and Cystatin C (p = 0.86 ).

Countries

Brazil

Contacts

Public Contactgabriel castro

Faculdade de Medicina de Botucatu UNESP

trictracxliv@yahoo.com.br+55-016-981980408

Outcome results

None listed

Source: REBEC (via WHO ICTRP)