---
title: Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.
nct_id: NCT00738504
overall_status: COMPLETED
sponsor: Hospital Sao Domingos
study_type: OBSERVATIONAL
primary_condition: Kidney
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00738504.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00738504"
ct_last_update_post_date: 2008-08-20
last_seen_at: "2026-05-12T07:28:41.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.

**Official Title:** INTENSIVE INSULIN THERAPY REALLY REDUCES THE INCIDENCE OF ACUTE KIDNEY INJURY IN CRITICALLY ILL PATIENTS? An Analysis Using the RIFLE Criteria for Definition of Acute Kidney Injury.

**NCT ID:** [NCT00738504](https://clinicaltrials.gov/study/NCT00738504)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 337
- **Lead Sponsor:** Hospital Sao Domingos
- **Conditions:** Kidney, Injury
- **Start Date:** 2008-06
- **CT.gov Last Update:** 2008-08-20

## Brief Summary

The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission.

Exclusion Criteria:

* pregnant patients
```

## Arms

- **1**
- **2**
- **Group 1** — Group 1 (Carbohydrate Restrictive Strategy). Patients received intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16,7% proteins and 50% lipids (Glucerna, Abbott Laboratories). These patients received regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and, in stable patients, ideally below 150 mg/dl.
- **Group 2** — Group 2 (Intensive Insulin Therapy). Continuous intravenous insulin infusion was adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 to 120 mg/dl. Patients were submitted to capillary glycemic measurements every 2 hours. The insulin dose was adjusted according to an algorithm run by nurses and overseen by physicians. These patients received glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids (Diason, Nutricia Clinical Care Ltd).

## Primary Outcomes

- **To compare the renal function outcome, defined by the RIFLE criteria in patients submitted to two different regimens of glycemic control: a carbohydrate restrictive strategy and intensive insulin therapy.**

## Locations (1)

- Hospital Sao Domingos, São Luís, Maranhão, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital sao domingos|são luís|maranhão|brazil` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00738504*  
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